A Double-Blinded, Placebo-controlled, Double Dummy, Multi-center Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on One to Three Glucose-lowering Agents

ORA-013-3 is a randomized, controlled study to test the efficacy and safety of an oral capsule of ORMD-0801 at several doses in patients with Type 2 Diabetes Mellitus (T2DM) who have not responded well to other glucose-lowering medications. A total of three hundred subjects will be enrolled in this study and will be required to complete this thirty-four-week clinical trial.

Start Date15 Dec 2025

Sponsor / Collaborator

Oramed Ltd.

[+1]

CTR20244337

/ CompletedPhase 1

一项开放、随机、两周期、两交叉、评价人胰岛素肠溶胶囊在中国健康男性受试者中的药效动力学、药代动力学及相对生物有效性、相对生物利用度研究

[Translation] An open, randomized, two-period, two-crossover study to evaluate the pharmacodynamics, pharmacokinetics, relative bioavailability and relative bioavailability of human insulin enteric-coated capsules in healthy Chinese male subjects

主要目的：本研究采用高胰岛素-正葡萄糖钳夹技术作为测试方法，对人胰岛素肠溶胶囊进行药效动力学研究，对比人胰岛素肠溶胶囊与人胰岛素注射液(天麦霖® R)的相对生物有效性。次要目的：对人胰岛素肠溶胶囊进行药代动力学研究，对比人胰岛素肠溶胶囊与人胰岛素注射液(天麦霖® R)的相对生物利用度。

[Translation]

Main purpose: This study used the hyperinsulinemic-euglycemic clamp technique as the test method to conduct a pharmacodynamic study on human insulin enteric-coated capsules and compare the relative bioavailability of human insulin enteric-coated capsules and human insulin injection (Tianmailin® R). Secondary purpose: The pharmacokinetic study of human insulin enteric-coated capsules was conducted to compare the relative bioavailability of human insulin enteric-coated capsules and human insulin injection (Tianmailin® R).

Start Date17 Jul 2024

Sponsor / Collaborator

Israel Oramd Co Ltd

[+3]

NCT04817215

/ Unknown statusPhase 3IIT

A Double-Blinded, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Uncontrolled Type 2 DM Subjects on Diet Control Alone, Metformin Monotherapy, or Two or Three Oral Glucose-lowering Agents

To compare the efficacy of ORMD-0801 to placebo in improving glycemic control as assessed by A1C in inadequately controlled T2DM subjects on diet control alone or on diet control and metformin monotherapy or two or three oral glucose-lowering agents.
To assess the safety of repeat administration of ORMD-0801 in inadequately controlled T2DM subjects on on diet control alone or on diet control and metformin monotherapy or two or three oral glucose-lowering agents.

Start Date01 Oct 2021

Sponsor / Collaborator

King Hamad General Hospital

[+2]

100 Clinical Results associated with Insulin (Oramed)

100 Translational Medicine associated with Insulin (Oramed)

100 Patents (Medical) associated with Insulin (Oramed)

Literatures (Medical) associated with Insulin (Oramed)

01 Dec 2025·DIABETES OBESITY & METABOLISM

Pharmacokinetics and pharmacodynamics of oral insulin ( ORMD ‐0801) in healthy subjects: A phase I study using hyperinsulinaemic‐euglycaemic clamp

Article

Author: Zhou, Yingxia ; Chen, Yufei ; Lu, Jiangjie ; Ning, Guang ; Wang, Jiayi ; Lv, Qing ; Wang, Weiqing ; Shi, Jia ; Zhou, Jie ; Gao, Ya ; Ma, Ming ; Zhang, Yifei ; Sheng, Haiyuan ; Shao, Ting ; Hu, Zhuomeng

Abstract:

Aims:

To characterise the pharmacokinetic (PK) and pharmacodynamic (PD) properties of an oral insulin formulation (ORMD‐0801) in healthy subjects.

Materials and Methods:

In this phase I hyperinsulinaemic‐euglycaemic clamp study with open‐label, randomised, crossover design, 20 healthy Chinese male subjects were randomised to receive either oral ORMD ‐0801 (8 or 16 mg), followed by subcutaneous ( SC ) insulin (5 IU , Tianmailin®) or vice versa. PK and PD parameters were evaluated by assessing changes in plasma insulin levels and glucose infusion rate ( GIR ) during an 11‐h clamp procedure.

Results:

For 16 mg oral versus SC insulin, maximum GIR (GIR max) was 3.87 ± 1.08 versus 3.51 ± 0.52 mg/kg/min, and area under the glucose infusion rate curve from 0 to 11 h (AUC GIR0–11h ) was 26.98 ± 10.69 versus 23.74 ± 9.04 h·mg/kg/min. For 8 mg oral versus SC insulin, GIR max was 3.86 ± 1.25 versus 5.41 ± 3.05 mg/kg/min, and AUC GIR0–11h was 27.07 ± 8.43 versus 29.95 ± 7.70 h·mg/kg/min. SC‐equivalent doses were 6.53 ± 3.97 IU (16 mg) and 4.62 ± 1.13 IU (8 mg), respectively. PK analysis showed area under the insulin concentration–time curve from zero to infinite (AUC Ins0‐∞ ) of 5.47 ± 3.17 versus 7.50 ± 2.37 h·ng/mL for 16 mg oral versus SC insulin, and 4.86 ± 2.89 versus 7.85 ± 2.02 h·ng/ mL for 8 mg oral versus SC insulin, with relative bioavailability of 0.53 ± 0.25% and 0.94 ± 0.77%.

Conclusions:

This study comprehensively describes the PK/PD characteristics of ORMD‐0801 in healthy subjects and provides a basis for future clinical trials.

01 Jan 2024·Gastro hep advances

Oral Insulin Alleviates Liver Fibrosis and Reduces Liver Steatosis in Patients With Metabolic Dysfunction-associated Steatohepatitis and Type 2 Diabetes: Results of Phase II Randomized, Placebo-controlled Feasibility Clinical Trial

Article

Author: Lopez, Oliver ; Katchman, Helena ; Neutel, Joel ; Kidron, Miriam ; Kolben, Yotam ; Ishay, Yuval ; Mohseni, Rizwana ; Gelman, Ram ; Ilan, Yaron ; Arbib, Orly Sneh

Background and Aims:

Metabolic dysfunction-associated steatohepatitis is an advanced form of nonalcoholic fatty liver disease and a leading cause of end-stage liver disease and transplantation. Insulin resistance and inflammation underlie the pathogenesis of the disease.

Methods:

This double-blind, randomized, placebo-controlled, multicenter feasibility clinical trial aimed to determine the safety of oral 8 mg insulin in patients with metabolic dysfunction-associated steatohepatitis and type 2 diabetes mellitus. Patients were treated twice daily for 12 weeks with an 8 mg insulin (n = 21) or placebo (n = 11) capsule. Safety was monitored throughout the study. MRI-proton density fat fraction assessed liver fat content, and Fibroscan® measured liver fibrosis and steatosis levels at screening and after 12 weeks of treatment.

Results:

No severe drug-related adverse events were reported during the study. After 12 weeks of treatment, mean percent reductions in whole-liver (-11.2% vs -6.5%, respectively) and liver segment 3 (-11.7% vs +0.1%, respectively) fat content was higher in the insulin than in the placebo arm. Patients receiving insulin showed a median -1.2 kPa and -21.0 dB/m reduction from baseline fibrosis and steatosis levels, respectively, while placebo-treated patients showed median increases of 0.3 kPa and 13.0 dB/m, respectively. At Week 12, oral insulin was associated with a mean of 0.27% reduction and placebo with a 0.23% increase from baseline hemoglobin A1c levels. Mean percent changes from baseline alanine aminotransferase, and aspartate aminotransferase levels were -10% and -0.8%, respectively, in the oral insulin and 3.0% and 13.4%, in the placebo arm.

Conclusion:

The results of this feasibility study support the safety and potential therapeutic effect of orally delivered insulin on liver fibrosis, fat accumulation, and inflammatory processes (NIH Clinical Trials No. NCT04618744).

01 Apr 2023·Diabetes, obesity & metabolism

Oral insulin ( ORMD ‐0801) in type 2 diabetes mellitus: A dose‐finding 12‐week randomized placebo‐controlled study

Article

Author: Roy Eldor ; Joel Neutel ; Miriam Kidron ; Julio Rosenstock ; Alexander Fleming ; Kenneth Homer ; Bruce H. Francis

Abstract:

Aims:

To assess the safety and efficacy of multiple daily doses of oral insulin (ORMD‐0801) in subjects with type 2 diabetes (T2DM) over 12 weeks.

Materials and Methods:

Participants with T2DM on metformin or combination oral therapy with glycated haemoglobin (HbA1c) levels ≥ 7.5% (58 mmol/mol) were randomized to receive ORMD‐0801 8 mg or 16 mg once (QD) or twice (BID) daily, or 32 mg QD, BID or three times daily (TID) over a 12‐week period.

Results:

A total of 373 subjects were randomized to active treatment or placebo (~60% male, age ~ 56 years, HbA1c 9%‐9.8%; 75‐84 mmol/mol). Placebo‐adjusted HbA1c changes from baseline to Week 12 were observed with ORMD‐0801 8 mg BID (−7.15 ± 3.57 mmol/mol [−0.65% ± 0.33%]; P = 0.046). However, a significant site interaction was observed in two sites. After excluding these, HbA1c reduction was observed with 8 mg QD (−0.81 ± 0.37%; −8.89 ± 4.01 mmol/mol; P = 0.028, n = 15), 8 mg BID (−0.82 ± 0.37%; −8.95 ± 4.08 mmol/mol; P = 0.029, n = 17), 32 mg QD (−0.54 ± 0.26%; −5.89 ± 2.78 mmol/mol; P = 0.036, n = 69) and 32 mg BID (−0.53 ± 0.26%; −5.80 ± 2.83 mmol/mol; P = 0.042, n = 68). No effect was observed with 16 mg QD (0.25 ± 0.37%; 2.76 ± 3.99 mmol/mol; P = 0.48, n = 18), 16 mg BID (−0.36 ± 0.40%; −3.97 ± P = 0.36, n = 15) or 32 mg TID (−0.45 ± 0.27%, −4.89 ± 2.90 mmol/mol; P = 0.093, n = 69). Continuous glucose monitor and serum glucose measurements showed similar trends but were not significant. ORMD‐0801 was safe, well tolerated and not associated with weight gain or hypoglycaemia.

Conclusions:

Oral insulin (ORMD‐0801) induced greater reductions in HbA1c when compared to placebo, and was safe and well tolerated in individuals with uncontrolled T2DM. The efficacy and safety findings support continued development of the 8‐mg dose at bedtime, which is currently being evaluated in two Phase 3 trials.

News (Medical) associated with Insulin (Oramed)

18 Mar 2026

·www.biospace.com

Lifeward Reports Fourth Quarter and Full Year 2025 Financial Results

Advancing t ransformation into a d iversified b iomedical i nnovation c ompany with a c lear p ath to c ash f low p ositiv e Oramed s trategic t ransaction r eceives s hareholder a pproval ; Lifeward g ain s n ew o ral p rotein d elivery t echnology p latform Lifeward a lready e xecuting n ew s trategy t hrough a cquisition of p owered u pper- b ody e xoskeleton t echnology Lower operating expenses and cash usage reflect improved operational efficiency HUDSON, Mass. and YOKNEAM ILLIT, Israel, March 18, 2026 (GLOBE NEWSWIRE) -- Lifeward Ltd. (Nasdaq: LFWD) (“Lifeward” or the “Company”), a global leader in innovative medical technology to transform the lives of people with physical limitations or disabilities, today announced its financial results for the fourth quarter and full year ended December 31, 2025. “We are entering 2026 with a pivotal transaction that establishes Lifeward as a diversified biomedical innovation company positioned for long-term growth and sustainability,” said Mark Grant, CEO of Lifeward. “The transformative strategic investment agreement with Oramed introduces an entirely new technology platform to Lifeward through Oramed’s Protein Oral Delivery (POD™) technology, while Oramed continues to fund and manage development of the clinical pipeline, whose lead asset is oral insulin. This transaction significantly expands our innovation pipeline while allowing us to maintain focus on operational execution and growth in our core neuro-rehabilitation Medtech business.” “With shareholder approval secured and the transaction expected to close shortly, we believe this partnership, which includes financing agreements with Oramed, provides a cash runway and positions Lifeward on a clear path toward achieving cash flow positive. While 2025 was a transition year for Lifeward as we repositioned the Company for its next phase of growth, in 2026 we are already executing on our strategy to become a diversified biomedical innovation company. Our acquisition of a powered upper-body exoskeleton technology is a strong example of this approach: it complements our ReWalk® platform, leverages the same sales, distribution and reimbursement infrastructure we have already built, and adds scale to our operations while delivering life-enhancing solutions to patients. As we continue to evaluate additional accretive transactions and build a robust pipeline of high-value clinical assets, we remain focused on growing revenues through our commercialized neuro-rehabilitation products and achieving positive cash flow,” Grant concluded. Recent Corporate Highlights Transformative Strategic Agreement with Oramed Lifeward has received shareholder approval for a transformative strategic investment and technology collaboration agreement with Oramed Pharmaceuticals. Lifeward will acquire Oramed’s clinical-stage proprietary POD™ technology platform while Oramed receives up to 49.99% equity ownership of Lifeward. The transaction positions the Company to participate in the development of oral biologic therapies and to receive up to $47 million in additional funding from Oramed, providing a runway to cash flow positive. Importantly, Oramed will fund the clinical development associated with the platform, enabling Lifeward to access a potentially high-value technology while limiting capital requirements. ORMD-0801, the POD™ technology’s lead drug candidate, has the potential to create a new paradigm in the treatment of type 2 diabetes by orally delivering insulin at an earlier stage of treatment. Earlier treatment has the potential to curb disease progression and delay late-stage complications. Based on an extensive analysis of Phase 2 and Phase 3 data, Oramed plans to initiate a 60-patient U.S.-based clinical trial. Lifeward anticipates closing the transaction following the satisfaction of additional customary closing conditions. Executing Strategic Expansion Through Acquisition of Upper-Body Exoskeleton Technology Demonstrating early execution of its new strategic direction, Lifeward has entered into an agreement to acquire a powered upper-body exoskeleton technology with integrated AI capabilities. The technology is designed to assist individuals with upper-limb mobility limitations and represents a natural extension of Lifeward’s leadership in wearable robotic rehabilitation solutions. The platform is highly complementary to Lifeward’s existing ReWalk ecosystem, enabling the Company to leverage its established clinical relationships, distribution network and reimbursement channels to accelerate commercialization and deliver innovative solutions to a broader patient population. Lifeward expects the new upper-body exoskeleton to be ready for commercial launch within approximately 18 to 24 months, following additional development and regulatory approvals, and expects attractive gross margins and favorable unit economics over time. Expanding Reimbursement Coverage for ReWalk Personal Exoskeleton Lifeward achieved meaningful progress in reimbursement coverage for the ReWalk Personal Exoskeleton with Aetna, Humana, and UnitedHealthcare all adding Medicare Advantage coverage for the device. Together, these payers provide access to approximately 16 million covered lives in the United States. This milestone represents a significant step forward in improving patient access and reinforces the growing recognition of the clinical value of robotic exoskeleton technology for individuals with spinal cord injuries. Advancing Clinical Collaboration with Shirley Ryan AbilityLab Lifeward also announced a collaboration with Shirley Ryan AbilityLab, a globally recognized leader in rehabilitation research and care. The collaboration is designed to expand clinical research and training initiatives aimed at improving patient outcomes and advancing the use of robotic rehabilitation technologies. Through this partnership, Lifeward expects to further strengthen clinical evidence supporting its technologies and accelerate adoption across rehabilitation centers. Expanding International Distribution of ReWalk Personal Lifeward continued to grow its global footprint by expanding international distribution of the ReWalk® Personal Exoskeleton into Mexico, Thailand, and the United Arab Emirates through an agreement with Verita Neuro in a partner-led and capital-efficient model. Transformation of U.S. Sales and Distribution Infrastructure During the latter half of 2025, Lifeward advanced a significant transformation of its U.S. commercial infrastructure, transitioning to a hybrid sales model that combines direct efforts with strategic channel partnerships. These partnerships require time to scale and are not yet fully reflected in current revenue. Lifeward’s U.S. commercial structure is now focused across three key areas: direct-to-patient engagement, capital equipment sales to institutional customers, and expanded payer and reimbursement capabilities. Strengthening reimbursement remains central to the Company’s strategy, as it enhances patient access and supports broader adoption of its neuro-rehabilitation products. These initiatives are expected to improve sales execution, deepen payer relationships, and drive meaningful growth as their impact builds in the coming quarters. Operational Efficiency Continues to Improve Throughout 2025, Lifeward maintained a strong focus on operational discipline and efficiency, achieving improvements in operating performance on both a quarterly and full-year basis. GAAP operating expenses for the full year decreased by 25%, while non-GAAP operating expenses, which do not include a one-time impairment charge and better reflect the ongoing improvements in operations efficiency, declined by 12%. These efforts support Lifeward’s objective of driving sustainable growth and achieving positive cash flow while building high-value clinical assets that address substantial unmet clinical needs. Fourth Quarter 2025 Financial Results Revenue was $5.1 million in the fourth quarter of 2025, compared to $7.5 million in the fourth quarter of 2024, a decrease of $2.4 million, or approximately 33%. Revenue from the sale of ReWalk Personal exoskeletons increased by 20% to $1.8 million in the fourth quarter of 2025 compared to the same period in 2024 driven by higher reimbursed unit sales. This was partially offset by a decline in sales of the MyoCycle FES bike by 90% to $0.1 million, primarily reflecting the transition away from an exclusive distribution arrangement and the Company’s strategic focus on its proprietary product portfolio. Revenue from the sale of AlterG products and services was $3.2 million, a decline of 43% from the same period in 2024. This was primarily due to timing factors from one international distributor that placed larger orders in Q4 2024 and plans to resume orders in 2026. Gross margin was 21.4% during the fourth quarter of 2025, compared to 24.4% in the fourth quarter of 2024. On a non-GAAP basis, which excludes the amortization of purchase price allocation adjustments, stock-based compensation expense, and inventory write-downs, as detailed in the attached non-GAAP reconciliation table, adjusted gross margin was 32.6% in the fourth quarter of 2025, compared to 45.5% in the prior-year quarter. The year-over-year decrease was primarily driven by lower sales volumes and the resulting reduced absorption of fixed manufacturing overhead, as well as higher tariffs and freight expenses. Total operating expenses in the fourth quarter of 2025 declined by 64% to $6.2 million, from $17.1 million in the fourth quarter of 2024. The decrease is primarily attributable to an impairment charge related to certain acquired intangible assets recognized in the fourth quarter of 2024, in addition to reductions in R&D and sales and marketing expenses. On a non-GAAP basis, which excludes the items listed in the attached non-GAAP reconciliation table, adjusted operating expenses declined by 16% to $5.7 million in the fourth quarter of 2025, compared to $6.7 million in the fourth quarter of 2024. This decrease primarily reflects improved productivity in marketing and sales operations, and lower R&D spending after the completion of major development programs. The Company expects this positive trend in marketing and sales efficiencies to continue into 2026, as it increases investments in R&D to advance new products to market. Operating loss in the fourth quarter of 2025 declined by 66% to $5.1 million, from $15.2 million in the fourth quarter of 2024, primarily due to a $9.8 million impairment charge in the fourth quarter of 2024. On a non-GAAP basis, which excludes the items in the attached non-GAAP reconciliation table, adjusted operating loss increased by 22% to $4.0 million in the fourth quarter of 2025, from $3.3 million in the fourth quarter of 2024. Net loss narrowed by 65% to $5.3 million, or $3.60 per share in the fourth quarter of 2025, from $15.3 million, or $20.82 per share, in the fourth quarter of 2024. On a non-GAAP basis, which excludes the items in the attached non-GAAP reconciliation table, adjusted net loss increased by 27% to $4.2 million, or $2.85 per share, in the fourth quarter of 2025, from $3.3 million, or $4.54 per share, during the fourth quarter of 2024. F ull Year 2025 Financial Results Revenue for the year ended December 31, 2025 was $22.0 million, compared to $25.7 million in 2024, a decrease of $3.7 million, or approximately 14%. Revenue from the sale of ReWalk Personal exoskeletons decreased by 3% to $8.5 million in 2025 compared to $8.9 million in 2024. Sales of the MyoCycle FES bike declined by 50% to $0.6 million, primarily reflecting the transition away from an exclusive distribution arrangement and the Company’s strategic focus on its proprietary product portfolio. Revenue from the sale of AlterG products and services was $12.9 million, a decline of 18% from 2024. This decrease was primarily attributable to lower international sales, partially due to timing factors related to one international distributor that had placed larger orders in 2024 and is expected to resume orders in 2026. Gross margin grew to 38.2% in 2025 from 32.0% in 2024. On a non-GAAP basis, which excludes the amortization of purchase price allocation adjustments, restructuring costs, inventory write-downs and stock-based compensation expense as detailed in the attached non-GAAP reconciliation table, adjusted gross margin declined to 40.9% in 2025 from 42.7% in the prior year, primarily driven by lower sales volumes and the resulting reduced absorption of fixed manufacturing overhead, as well as higher tariffs and freight expenses. Total operating expenses in 2025 declined by 25% to $28.1 million, from $37.6 million in 2024. The decrease is primarily attributable to an impairment charge related to certain acquired intangible assets recognized in the fourth quarter of 2024, compared to a $2.8 million goodwill impairment charge recognized in 2025. The decline also reflects greater efficiency in reimbursement activities, reductions in R&D and sales and marketing expenses. On a non-GAAP basis, which excludes the items listed in the attached non-GAAP reconciliation table, adjusted operating expenses declined by 12% to $24.1 million in 2025 from $27.5 million in 2024 due to improved productivity in marketing and sales operations, greater efficiency in reimbursement activities, and lower R&D spending after the completion of major development programs. Operating loss in 2025 declined by 33% to $19.7 million from $29.3 million in 2024, primarily due to a $9.8 million impairment charge in 2024. On a non-GAAP basis, which excludes the items in the attached non-GAAP reconciliation table, adjusted operating loss narrowed by 9% to $15.1 million in 2025 from $16.6 million in 2024. Net loss narrowed by 31% to $19.9 million, or $17.16 per share in 2025 from $28.9 million, or $39.96 per share, in 2024. On a non-GAAP basis, which excludes the items in the attached non-GAAP reconciliation table, adjusted net loss narrowed by 5% to $15.4 million, or $13.23 per share, in 2025 from $16.2 million, or $22.33 per share in 2024. Liquidity As of December 31, 2025, Lifeward had $2.2 million in unrestricted cash and cash equivalents on its balance sheet. Lifeward expects to close the strategic transaction following the satisfaction of additional customary closing conditions, at which time the Company plans to close on its secured convertible note with Oramed and another investor. About Lifeward Lifeward designs, develops, and commercializes life-changing solutions that span the continuum of care in physical rehabilitation and recovery, delivering proven functional and health benefits in clinical settings as well as in the home and community. Our mission at Lifeward is to relentlessly drive innovation to change the lives of individuals with physical limitations or disabilities. We are committed to delivering groundbreaking solutions that empower individuals to do what they love. The Lifeward portfolio features innovative products including the ReWalk Exoskeleton, the AlterG Anti-Gravity system, the MyoCycle FES System, and the ReStore Exo-Suit. Founded in 2001, Lifeward has operations in the United States, Israel, and Germany. For more information on the Lifeward mission and product portfolio, please visit G o L ifeward.com . Lifeward ® , ReWalk ® , ReStore ® and Alter G ® are registered trademarks of Lifeward Ltd. and/or its affiliates. Forward-Looking Statements In addition to historical information, this press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, Section 27A of the U.S. Securities Act of 1933, and Section 21E of the U.S. Securities Exchange Act of 1934 concerning Lifeward, Oramed, the strategic investment and partnership agreement with Oramed (collectively, the “Proposed Transactions”) and other matters. Such forward-looking statements may include projections regarding the Company's future performance and other statements that are not statements of historical fact and, in some cases, may be identified by words like "anticipate," "assume," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "future," "will," "should," "would," "seek" and similar terms or phrases. The forward-looking statements contained in this press release are based on management's current expectations, which are subject to uncertainty, risks and changes in circumstances that are difficult to predict and many of which are outside of the Company’s control. Important factors that could cause the Company’s actual results to differ materially from those indicated in the forward-looking statements include, among others: Lifeward’s and Oramed’s management teams’ expectations, hopes, beliefs, intentions or strategies regarding the future including, without limitation, statements regarding: the structure, timing and completion of the Proposed Transactions; perceived benefits or opportunities of the Proposed Transactions; timing of closing of the Proposed Transactions, expected proceeds, expectations regarding the use of proceeds, and impact on ownership structure; the anticipated timing of the closing; the future operations of Lifeward, including research and development activities; the nature, strategy and focus of Lifeward; anticipated clinical drug development activities and related timelines, and other clinical results; the sufficiency of post-transaction resources to support the advancement of Lifeward’s pipeline through certain milestones and the time period over which Lifeward’s post-transaction capital resources will be sufficient to fund its anticipated operations; unexpected costs, charges or expenses resulting from the Proposed Transactions; potential adverse reactions or changes to business relationships resulting from the announcement or completion of the Proposed Transactions; and legislative, regulatory, political and economic developments; the acceptance of the ReWalk 7 Personal Exoskeleton by healthcare professionals and patients; uncertainties associated with future clinical trials and the clinical development process, the product development process and FDA regulatory submission review and approval process; the Company's ability to have sufficient funds to meet certain future capital requirements, which could impair the Company's efforts to develop and commercialize existing and new products; the Company's ability to maintain and grow its reputation and the market acceptance of its products; the Company's ability to achieve reimbursement from third-party payors, including CMS, for its products; the Company's limited operating history and its ability to leverage its sales, marketing and training infrastructure; the Company's expectations as to its clinical research program and clinical results; the Company's expectations regarding future growth, including its ability to increase sales in its existing geographic markets and expand to new markets; the Company’s ability to continue to operate as a going concern; the Company's ability to obtain certain components of its products from third-party suppliers and its continued access to its product manufacturers; the Company’s ability to navigate any difficulties associated with moving production of its AlterG Anti-Gravity Systems to a contract manufacturer and transitioning the manufacturing of its ReWalk products to its in-house manufacturer; the Company's ability to improve its products and develop new products; the Company's compliance with medical device reporting regulations to report adverse events involving the Company's products, which could result in voluntary corrective actions or enforcement actions such as mandatory recalls, and the potential impact of such adverse events on the Company's ability to market and sell its products; the Company's ability to gain and maintain regulatory approvals; the Company's ability to maintain adequate protection of its intellectual property and to avoid violation of the intellectual property rights of others; the risk of a cybersecurity attack or breach of the Company's IT systems significantly disrupting its business operations; the Company's ability to use effectively the proceeds of its offerings of securities; and other factors discussed under the heading "Risk Factors" in the Company’s annual report on Form 10-K, as amended, for the year ended December 31, 2025 filed with the SEC and other documents subsequently filed with or furnished to the SEC. Any forward-looking statement made in this press release speaks only as of the date hereof. Factors or events that could cause the Company’s actual results to differ from the statements contained herein may emerge from time to time, and it is not possible for the Company to predict all of them. Except as required by law, the Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise. Non-GAAP Financial Measures To supplement its consolidated financial statements, which are prepared and presented in accordance with U.S. Generally Accepted Accounting Principles (“GAAP”), the Company believes that the use of non-GAAP accounting measures, including non-GAAP net loss, is helpful to its investors. These measures, which the Company refers to as non-GAAP financial measures, are not prepared in accordance with GAAP. Because of varying available valuation methodologies, subjective assumptions, and the variety of equity instruments that can impact a company’s non-cash expenses, the Company believes that providing non-GAAP financial measures that exclude non-cash share-based compensation expense and acquisition costs allows for more meaningful comparisons between operating results from period to period. Each of the Company’s non-GAAP financial measures is an important tool for financial and operational decision-making and for the Company’s evaluation of its operating results over different periods of time. The non-GAAP financial data are not measures of the Company’s financial performance under U.S. GAAP and should not be considered as alternatives to operating loss or net loss or any other performance measures derived in accordance with GAAP. Non-GAAP financial measures may not provide information that is directly comparable to that provided by other companies in Lifeward’s industry, as other companies in the industry may calculate non-GAAP financial results differently, particularly related to non-recurring, unusual items. In addition, there are limitations in using non-GAAP financial measures because the non-GAAP financial measures are not prepared in accordance with GAAP, may be different from non-GAAP financial measures used by other companies and exclude expenses that may have a material impact on the Company’s reported financial results. Further, share-based compensation expense has been, and will continue for the foreseeable future, to be a significant recurring expense in the Company’s business and an important part of the compensation provided to its employees. The presentation of non-GAAP financial information is not meant to be considered in isolation or as a substitute for the directly comparable financial measures prepared in accordance with GAAP. Lifeward urges investors to review the reconciliation of the Company’s non-GAAP financial measures to the comparable GAAP financial measures included below, and not to rely on any single financial measure to evaluate the Company’s business. Lifeward does not provide GAAP reconciliation of its non-GAAP financial guidance because the Company is unable to predict with reasonable certainty and without unreasonable effort items that would be included in such a reconciliation, including, but not limited to, stock-based compensation expense, acquisition-related expense, and earnout expense. The timing and amounts of these items are uncertain and could be material to Lifeward’s results computed in accordance with GAAP. Contact: Almog Adar Chief Financial Officer Lifeward E: media@golifeward.com E: ir@golifeward.com Lifeward Ltd. And subsidiaries Condensed Consolidated Statements of Operations (Audited) (In thousands, except share and per share data) Quarter Ended Year Ended December 31, December 31, 2025 2024 2025 2024 Revenue $ 5,081 $ 7,545 $ 22,034 $ 25,663 Cost of revenues 3,993 5,701 13,606 17,447 Gross profit 1,088 1,844 8,428 8,216 Operating expenses: Research and development, net 843 1,131 3,249 4,625 Sales and marketing 3,085 4,376 13,875 17,949 General and administrative 2,278 1,771 8,195 5,195 Impairment charges - 9,794 2,783 9,794 Total operating expenses 6,206 17,072 28,102 37,563 Operating loss (5,118 ) (15,228 ) (19,674 ) (29,347 ) Financial (expense) income, net (303 ) (47 ) (295 ) 448 Loss before income taxes (5,421 ) (15,275 ) (19,969 ) (28,899 ) Taxes on income (benefit) (73 ) 3 (55 ) 43 Net loss $ (5,348 ) $ (15,278 ) $ (19,914 ) $ (28,942 ) Basic net loss per ordinary share $ (3.60 ) $ (20.82 ) $ (17.16 ) $ (39.96 ) Weighted average number of shares used in computing net loss per ordinary share basic and diluted (*) 1,487,519 733,965 1,160,521 724,272 (*) All share and per share amounts presented in this note have been retroactively adjusted to reflect the Company’s 1-for-12 reverse share split effected on February 24, 2026. Lifeward Ltd. And subsidiaries Condensed Consolidated Balance Sheets (Audited) (In thousands) December 31, December 31, 2025 2024 Assets Current assets Cash and cash equivalents $ 2,169 $ 6,746 Restricted Cash 240 197 Trade receivables, net of credit losses of $192 and $160, respectively 6,138 6,004 Prepaid expenses and other current assets 1,528 1,624 Inventories 5,732 6,723 Total current assets 15,807 21,294 Restricted cash and other long term assets 209 240 Operating lease right-of-use assets 1,544 548 Property and equipment, net 585 867 Goodwill 4,755 7,538 Total assets $ 22,900 $ 30,487 Liabilities and equity Current liabilities Trade payables 5,590 5,022 Current maturities of operating leases 425 858 Other current liabilities 3,221 3,737 Convertible promissory notes 2,803 - Earnout liability - 608 Total current liabilities 12,039 10,225 Non-current operating leases 1,159 22 Other long-term liabilities 1,294 1,391 Shareholders’ equity 8,408 18,849 Total liabilities and equity $ 22,900 $ 30,487 Lifeward Ltd. And subsidiaries Condensed Consolidated Statements of Cash Flows (Audited) (In thousands) Year Ended December 31, 2025 2024 Net cash used in operating activities $ (16,826 ) $ (21,718 ) Cash used in investing activities (16 ) - Net cash provided by financing activities 12,203 - Effect of Exchange rate changes on Cash, Cash Equivalents and Restricted Cash 110 34 Decrease in cash, cash equivalents, and restricted cash (4,529 ) (21,684 ) Cash, cash equivalents, and restricted cash at beginning of period 7,108 28,792 Cash, cash equivalents, and restricted cash at end of period $ 2,579 $ 7,108 Lifeward Ltd. And subsidiaries (Audited) (In thousand) Quarter Ended Year Ended December 31, December 31, 2025 2024 2025 2024 Revenues based on customer’s location: United States 2,974 3,371 13,237 14,425 Europe 807 2,489 2,907 5,124 Germany 805 1,161 4,014 4,422 Asia - Pacific 191 281 460 825 Rest of the world 304 243 1,416 867 Total Revenues $ 5,081 $ 7,545 $ 22,034 $ 25,663 Quarter Ended Year Ended December 31, December 31, Dollars in thousands, except per share data 2025 2024 2025 2024 GAAP net loss $ (5,348 ) $ (15,278 ) $ (19,914 ) $ (28,942 ) Adjustments: Amortization of intangible assets - 842 - 3,347 M&A transaction - - - (467 ) Integration/Rebranding costs - - - 236 Oramed transactions 384 - 384 - Restructuring - 1,260 700 1,260 Remeasurement of earnout liability - (184 ) (608 ) (2,684 ) Inventory Write down 562 - 562 - Impairment - 9,794 2,783 9,794 Stock-based compensation expenses 165 234 741 1,281 Non-GAAP net loss $ (4,237 ) $ (3,332 ) $ (15,352 ) $ (16,175 ) Shares used in net loss per share (*) 1,487,519 733,965 1,160,521 724,272 Non-GAAP net loss per share $ (2.85 ) $ (4.54 ) $ (13.23 ) $ (22.33 ) (*) All share and per share amounts presented in this note have been retroactively adjusted to reflect the Company’s 1-for-12 reverse share split effected on February 24, 2026. Quarter Ended Year Ended December 31, December 31, December 31, December 31, 2025 2024 2025 2024 Dollars in thousands $ % of revenue $ % of revenue $ % of revenue $ % of revenue GAAP operating loss $ (5,118 ) (100.7 )% $ (15,228 ) (201.8 )% $ (19,674 ) (89.3 )% $ (29,347 ) (114.4 )% Amortization of intangible assets - - 842 11.2 % - - 3,347 13.0 % M&A transaction - - - - - - (467 ) (1.8 )% Integration/Rebranding costs - - - - - - 236 0.9 % Oramed transactions 384 7.6 % - - 384 1.7 % - - Restructuring - - 1,260 16.7 % 700 3.2 % 1,260 4.9 % Remeasurement of earnout liability - - (184 ) (2.4 )% (608 ) (2.8 )% (2,684 ) (10.5 )% Inventory Write down 562 11.1 % - - 562 2.6 % - - Impairment - - 9,794 129.8 % 2,783 12.6 % 9,794 38.2 % Stock-based compensation expenses 165 3.2 % 234 3.1 % 741 3.4 % 1,281 5.0 % Non-GAAP operating loss $ (4,007 ) (78.8 )% $ (3,282 ) (43.4 )% $ (15,112 ) (68.6 )% $ (16,580 ) (64.7 )% Quarter Ended Year Ended December 31, December 31, December 31, December 31, 2025 2024 2025 2024 Dollars in thousands $ % of revenue $ % of revenue $ % of revenue $ % of revenue GAAP gross profit $ 1,088 21.4 % $ 1,844 24.4 % $ 8,428 38.2 % $ 8,216 32.0 % Adjustments: Inventory Write down 562 11.1 % - - 562 2.6 % - - Amortization of intangible assets - - 387 5.1 % - - 1,540 6.0 % Restructuring - - 1,195 15.8 % - - 1,195 4.7 % Stock-based compensation expenses 4 0.1 % 4 0.1 % 14 0.1 % 16 0.1 % Non-GAAP gross profit $ 1,654 32.6 % $ 3,430 45.4 % $ 9,004 40.9 % $ 10,967 42.8 % Quarter Ended Year Ended December 31, December 31, December 31, December 31, 2025 2024 2025 2024 Dollars in thousands $ % of revenue $ % of revenue $ % of revenue $ % of revenue GAAP research & development $ 843 16.6 % $ 1,131 15.0 % $ 3,249 14.7 % $ 4,625 18.0 % Adjustments: Stock-based compensation expenses (33 ) (0.6 )% (38 ) (0.5 )% (138 ) (0.6 )% (168 ) (0.7 )% Non-GAAP research & development $ 810 16.0 % $ 1,093 14.5 % $ 3,111 14.1 % $ 4,457 17.3 % Quarter Ended Year Ended December 31, December 31, December 31, December 31, 2025 2024 2025 2024 Dollars in thousands $ % of revenue $ % of revenue $ % of revenue $ % of revenue GAAP sales & marketing $ 3,085 60.7 % $ 4,376 58.0 % $ 13,875 63.0 % $ 17,949 69.9 % Adjustments: Amortization of intangible assets - - (388 ) (5.1 )% - - (1,542 ) (6.0 )% Integration/Rebranding costs - - - - - - - (193 ) (0.8 )% Restructuring - - - - (277 ) (1.3 )% - - Stock-based compensation expenses (36 ) (0.7 )% (92 ) (1.2 )% (239 ) (1.1 )% (401 ) (1.6 )% Non-GAAP sales & marketing $ 3,049 60.0 % $ 3,896 51.7 % $ 13,359 60.6 % $ 15,813 61.5 % Quarter Ended Year Ended December 31, December 31, December 31, December 31, 2025 2024 2025 2024 Dollars in thousands $ % of revenue $ % of revenue $ % of revenue $ % of revenue GAAP general & administrative $ 2,278 44.8 % $ 1,771 23.5 % $ 8,195 37.2 % $ 5,195 20.2 % Adjustments: M&A transaction - - - - - - 467 1.8 % Amortization of intangible assets - - (67 ) (0.9 )% - - (265 ) (1.0 )% Integration/Rebranding costs - - - - - - (43 ) (0.2 )% Oramed transactions (384 ) (7.6 )% - - (384 ) (1.7 )% - - Restructuring - - (65 ) (0.9 )% (423 ) (1.9 )% (65 ) (0.3 )% Remeasurement of earnout liability - - 184 2.4 % 608 2.8 % 2,684 10.5 % Stock-based compensation expenses (92 ) (1.8 )% (100 ) (1.3 )% (350 ) (1.6 )% (696 ) (2.7 )% Non-GAAP general & administrative $ 1,802 35.4 % $ 1,723 22.8 % $ 7,646 34.8 % $ 7,277 28.3 %

AcquisitionFinancial Statement

11 Apr 2025

·synapse.patsnap.com

Highlights of February 2025: Biopharmaceutical Clinical-Stage Drug Investment, Financing, and Collaboration Deals (2)

Our analysis of February data reveals key trends in global clinical-stage biopharmaceutical financing. For contextual understanding, we recommend beginning with the following article. Highlights of February 2025: Biopharmaceutical Clinical-Stage Drug Investment, Financing, and Collaboration Deals (1) 11. Kyorin and Cyrano Therapeutics Enter into an Option Agreement for the Development and Commercialization of CYR-064 in Japan On February 14, 2025, Kyorin Pharmaceutical Co., Ltd. and Cyrano Therapeutics, Inc. announced the signing of an option agreement for the novel drug CYR-064, which is designed to treat hyposmia following viral infections. Under the terms of this agreement, Kyorin has obtained the rights to develop and commercialize CYR-064 in Japan and will pay an option fee. Once the option is exercised and a licensing agreement is signed, Kyorin will also provide Cyrano with an upfront payment, milestone payments based on development and commercialization progress, and royalties calculated as a percentage of net sales after the product is launched. CYR-064 is a patented intranasal formulation of theophylline, a broad-spectrum phosphodiesterase inhibitor (PDEi), which increases intracellular cAMP levels by inhibiting cAMP degradation, thereby enhancing the excitability of olfactory neurons. This provides a potential therapeutic pathway for treating hyposmia following viral infections and other olfactory disorders. Currently, CYR-064 is undergoing a Phase II clinical trial in the United States, with trial data expected in the second half of 2025. Guided by its long-term vision "Vision 110," Kyorin Pharmaceutical is committed to creating high-value new drugs that meet medical needs. By actively leveraging open innovation strategies, Kyorin plans to continuously launch new drugs. This collaboration with Cyrano is part of its strategic implementation, aiming to accelerate the development and commercialization of CYR-064 in the Japanese market to address unmet medical needs. For the fiscal year ending in March 2025, this agreement is not expected to have a significant impact on Kyorin's business performance. However, with further development of CYR-064 and its potential market success, Kyorin anticipates positive financial returns in the coming years. Meanwhile, this collaboration also opens up new prospects for finding effective treatments for hyposmia following viral infections on a global scale. 12. Royalty Pharma Invests $250 Million to Support Biogen's Lupus Drug Litifilimab Development Royalty Pharma has entered into a $250 million agreement with Biogen to support the development of Biogen's late-stage experimental lupus drug litifilimab. Under the terms of the agreement, Biogen will receive this amount over the next six quarters. In return, if the drug achieves specific regulatory milestones, Royalty Pharma will receive undisclosed milestone payments and a mid-single-digit royalty on global sales. This transaction not only enhances Royalty Pharma's product portfolio but also brings more opportunities for potential revenue. Litifilimab is an anti-BDCA2 antibody currently in Phase III trials for systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE). The drug has demonstrated significant reduction in skin disease activity in the Phase II LILAC study, showing effective relief of skin symptoms in CLE patients compared to the placebo group at the primary endpoint. If approved by 2030, litifilimab is projected to achieve up to $750 million in global sales. This potential allows Biogen to use the funds to further advance its development process. Currently, the SLE market is dominated by generic drugs, with only a few targeted biologics approved by the U.S. Food and Drug Administration (FDA) in the past fifty years, such as GSK's Benlysta (belimumab) and AstraZeneca's Saphnelo (anifrolumab). In contrast, the CLE market is even more innovation-starved, with this form of lupus primarily affecting the skin, causing inflammation, rashes, and lesions. The successful development of litifilimab could change this status quo and provide new treatment options for patients. 13. Tivic Health Acquires Statera Biopharma's TLR5 Agonist Entolimod™ to Expand Its Therapeutic Pipeline Tivic Health Systems, Inc. has announced the acquisition of global exclusive rights to the late-stage Toll-like receptor 5 (TLR5) agonist Entolimod™ from Statera Biopharma for the treatment of acute radiation syndrome (ARS). In addition, Tivic has obtained exclusive options for five additional indications and clinical uses of Entolimod and its derivative Entalasta™. This extensive licensing agreement transforms Tivic into a diversified therapeutic company with complementary bioelectronic and biologic candidates in its clinical pipeline. As the lead candidate in the licensed portfolio, Entolimod is a TLR5 agonist specifically designed for the treatment of ARS. According to data from market research firm CoherentMI, the global ARS market was valued at $5.2 billion in 2024 and is projected to grow at a compound annual growth rate of 5% from 2024 to 2031. Entolimod and its immune-optimized derivative Entalasta have undergone over forty animal and human trials and received approximately $140 million in investment. The FDA has granted Entolimod Fast Track and Orphan Drug designations for the prevention or treatment of ARS and to prevent death following a potentially lethal dose of total-body ionizing radiation after a radiological disaster. Animal studies for ARS have shown that a single dose of Entolimod administered 25 hours after exposure to a lethal level of radiation can triple survival rates. The drug is effective without additional supportive care, demonstrating gastrointestinal protective properties and no dose-limiting toxicity even at the highest doses. Other studies have also shown its potential in applications such as immunosenescence, lymphocyte exhaustion, neutropenia, vaccine enhancement, and chronic radiation syndrome. Under the agreement, Tivic will initially pay Statera $1.2 million in equity consideration and $300,000 in cash for the use of Entolimod in treating ARS. Tivic has the option to add one or more indications and expand its licensing scope to Entolimod's derivative Entalasta by exercising the exclusive options granted in the agreement. Future potential payments will be royalty and milestone-driven, ensuring alignment with the clinical and commercial success of Entolimod and subsequent Entalasta. The agreement structure allows Tivic to strategically manage its investment while maximizing shareholder returns. To establish Tivic's biopharmaceutical capabilities and advance the product candidates toward commercialization, some members of Statera's team will join Tivic. The transaction also includes exclusive rights and options to over sixty patents and pending patents, related proprietary technology, and ownership of previously manufactured and tested materials. Craft Capital Management LLC served as the sole investment banking firm in this deal. With these resources integrated, Tivic is steadily moving toward becoming a leading biotherapeutic company. 14. Oramed Pharmaceuticals Announces Formation of OraTech Pharmaceuticals to Accelerate Development and Commercialization of Oral Insulin Oramed Pharmaceuticals Inc., a clinical-stage pharmaceutical company focused on the development of oral drug delivery platforms, recently announced that it will transfer its proprietary Protein Oral Delivery (POD™) technology to a new joint venture, OraTech Pharmaceuticals Inc., through a definitive agreement. This move is aimed at accelerating the development and commercialization of Oramed's oral insulin ORMD-0801 and other innovative oral drug delivery technologies based on the POD™ platform. In this transaction, Oramed will transfer its proprietary oral insulin and POD™ technology, along with other pipeline assets, to OraTech. Oramed shareholders will receive a majority stake in the new entity, allowing them to directly participate in its future success. Additionally, under the terms of the agreement, Oramed and HTIT will jointly invest $75 million, with Oramed contributing $15 million and HTIT contributing $60 million. This funding will provide OraTech with the necessary resources to advance product development, commercialization, and clinical progress. OraTech will leverage HTIT's expertise in capsule manufacturing and cost-effective production capabilities to establish a robust, reliable, and scalable supply chain to support clinical trials and commercial efforts. HTIT will also provide a supply agreement for the oral insulin capsules. Furthermore, OraTech plans to relaunch the pivotal Phase III clinical trial in the United States and advance the registration of oral insulin in the U.S. and other countries. In China, OraTech will receive royalties from the sales of oral insulin, while HTIT will be responsible for submitting marketing authorization applications and preparing for commercialization. 15. AdvanCell and Eli Lilly Expand Collaboration to Advance Cancer Targeted Alpha Therapy On February 10, 2025, AdvanCell announced that its strategic partnership with Eli Lilly and Company has been further expanded. This collaboration aims to research and develop innovative treatments for various types of cancer. The partnership not only recognizes AdvanCell's leadership in the field of Pb-212 targeted alpha therapy but also lays the foundation for a long-term collaboration between the two companies. Under the new cooperation agreement, both parties will utilize AdvanCell's proprietary Pb-212 production technology and radiopharmaceutical development infrastructure, as well as Eli Lilly's drug candidates and extensive drug development experience, to jointly advance the development of more targeted alpha radiopharmaceutical therapies and accelerate their clinical progress. AdvanCell's technological advantages and its infrastructure established in Australia to expedite early clinical trials enable it to quickly move novel radiotherapeutic drugs containing Pb-212 from the discovery phase to clinical trials. AdvanCell is currently conducting a Phase I/II trial for ADVC001, a potentially best-in-class targeted alpha therapy for metastatic prostate cancer. The trial aims to assess the safety and efficacy of the Pb-212-based radiopharmaceutical therapy. The core product ADVC001 is designed to bind to PSMA (a cell surface target highly expressed in prostate cancer) and has demonstrated potential best-in-class characteristics in preclinical studies. This collaboration is expected to accelerate the development of ADVC001, bringing new hope to patients with prostate cancer. As the partnership between AdvanCell and Eli Lilly continues to deepen, both parties are committed to achieving new breakthroughs in cancer treatment. By integrating their respective strengths and technologies, the two companies will not only accelerate the clinical progress of existing projects but also potentially open up new therapeutic pathways. For cancer patients who do not respond well to traditional therapies, targeted alpha therapy offers a more precise and less side-effect-prone treatment option. In the future, with the emergence of more research results, it is expected that more patients will benefit from this innovative cancer treatment method. 16. OliX and Eli Lilly Reach Global Licensing Agreement to Develop New Therapies for MASH and Other Cardiometabolic Indications On February 10, 2025, OliX Pharmaceuticals announced a global licensing agreement with Eli Lilly and Company. This cooperation aims to jointly develop and commercialize OliX's OLX75016, a Phase I candidate drug primarily targeting metabolic-associated fatty liver hepatitis (MASH) and other cardiometabolic indications. Under the terms of the agreement, OliX will receive an upfront payment from Eli Lilly to support the ongoing Phase I clinical trial in Australia. OLX75016 originates from robust targets identified through genome-wide association studies (GWAS), a method that can identify genomic variations in large populations. In preclinical studies, OliX has demonstrated the efficacy of OLX75016 in treating MASH, liver fibrosis, and other cardiometabolic indications. Currently, OliX is developing OLX75016 as a novel therapy for MASH with liver fibrosis and other cardiometabolic conditions. OliX Pharmaceuticals is a clinical-stage pharmaceutical company focused on developing treatments for various diseases using its proprietary RNAi technology. The company's core RNAi platform—Asymmetric siRNA (asiRNA)—is a unique gene-silencing technology based on RNA interference (RNAi) and is considered one of the most effective gene-silencing technologies currently available. Using this proprietary asiRNA technology, OliX has developed cell-penetrating asiRNA (cp-asiRNA), a therapeutic RNAi platform that effectively targets diseases such as proliferative scar formation, dry and wet age-related macular degeneration (AMD), and subretinal fibrosis. In addition to cp-asiRNA, OliX has also developed another therapeutic RNAi platform, GalNAc-asiRNA, specifically for targeting various liver diseases. This collaboration with Eli Lilly not only advances the development of OLX75016 but also further solidifies OliX's position in the biopharmaceutical field, demonstrating its commitment to addressing unmet medical needs through innovative technologies. As research and development progresses, it is anticipated that more new therapies based on these advanced technologies will emerge, bringing hope to patients worldwide. 17. Kineta Restructures Portfolio Ahead of Merger with TuHURA Ahead of its merger with TuHURA Biosciences, Kineta has made significant adjustments to its portfolio. To streamline its investments, Kineta decided to sell its collaboration deals with Genentech and Merck & Co. to an investment company and transferred its pain treatment candidate drug KCP506 to Pacira Pharmaceuticals, while also terminating its cooperation agreement with GigaGen. TuHURA purchased Kineta for $15 million, with $5 million allocated to secure the exclusivity agreement. This acquisition enabled TuHURA to acquire Kineta's Phase II checkpoint inhibitor. In 2018, Genentech paid Kineta a $5 million upfront payment to obtain the rights to a small molecule modulator and set milestone payments of up to $96 million. The collaboration was expanded in 2020 to support the early development phase of a pain treatment candidate drug. On the other hand, Kineta inherited a collaboration with Merck from its merger with Yumanity Therapeutics, which obtained a preclinical drug candidate for amyotrophic lateral sclerosis (ALS) and frontotemporal dementia from Yumanity in 2020. In 2023, Kineta received a $5 million milestone payment from Merck, with up to $255 million still pending. KCP506 is an α9α10 nicotinic acetylcholine receptor (nAChR) antagonist that Kineta is developing for the treatment of chronic neuropathic pain. Kineta initiated a Phase II trial for this drug. Subsequently, Kineta agreed to sell KCP506 to Pacira Pharmaceuticals for $450,000, marking the end of Kineta's further development of KCP506. A subsidiary of HealthCare Royalty Partners, HCRX Investments Holdco, reached an agreement with Kineta covering Kineta's licensing deals with Genentech and Merck, as well as its role in an agreement with Fair Therapeutics related to cystic fibrosis. This move will help Kineta focus its resources on the development of other key projects. Finally, Kineta decided to terminate its option and licensing agreement with GigaGen, which originally granted Kineta the rights to a CD27 drug program. By terminating this agreement, Kineta not only returned all rights to GigaGen but also waived its obligation to pay a $180,000 fee. This strategic retreat allows Kineta to concentrate more on the upcoming merger and the development of its core business. 18. Fosun Pharma and Dr. Reddy's Reach Licensing Agreement for HLX15 in Europe and the U.S. On February 6, 2025, Fosun Pharma announced a licensing agreement with Dr. Reddy's Laboratories for HLX15, a biosimilar to daratumumab, an anti-CD38 monoclonal antibody under development. HLX15 is a recombinant human anti-CD38 monoclonal antibody injection intended for the treatment of multiple myeloma and other hematologic malignancies. Under the agreement, Dr. Reddy's will obtain exclusive commercialization rights to the drug in 43 countries and regions, including 42 European countries and the United States. The collaboration aims to expand the drug's market coverage and provide advanced biologics to more patients. According to the terms of the agreement, Fosun Pharma will be responsible for the development, production, and commercial supply of HLX15 and may receive up to $131.6 million in funding from Dr. Reddy's, including a $33 million upfront payment and additional milestone payments. Additionally, Fosun Pharma will receive royalties based on annual net sales. This arrangement not only provides Fosun Pharma with the necessary cash flow to support its ongoing research and development but also enhances its competitiveness in the global market. HLX15, as a biosimilar, primarily works by targeting and inhibiting the function of the CD38 protein to combat multiple myeloma. CD38 is a protein highly expressed on the surface of certain cancer cells, and monoclonal antibodies targeting it can effectively identify and destroy these cells while minimizing impact on normal tissues. Therefore, HLX15 is expected to become an important option for treating such diseases. 19. Relmada Therapeutics Acquires Potential Tourette Syndrome Therapy Sepranolone from Asarina Pharma AB On February 6, 2025, Relmada Therapeutics announced the acquisition of Sepranolone from Asarina Pharma AB, a therapeutic asset for Tourette Syndrome (TS) and other compulsive-related disorders, ready to enter Phase IIb clinical trials. Sepranolone (isoallopregnanolone) is a first-in-class GABAA modulatory steroid antagonist (GAMSA) that selectively acts on the GABAA pathway, aiming to counteract the effects of allopregnanolone on TS and other compulsive disorders. An open-label Phase IIa randomized study showed that Sepranolone has the potential to improve TS symptoms, as measured by changes in the Yale Global Tic Severity Scale (YGTSS). In the 12-week study, Sepranolone not only reduced the primary clinical endpoint of tic severity by 28% (p=0.051) compared to standard care alone but also achieved positive results in four key secondary endpoints, including a 69% improvement in quality of life, a 50% reduction in functional impairment, and a 44% reduction in premonitory urges. Additionally, the drug did not exhibit off-target central nervous system effects or systemic adverse effects, which is a significant advantage for central nervous system disorders requiring long-term use and potentially severe side effects. Under the terms of the agreement, Relmada acquired global ownership of Sepranolone from Asarina Pharma AB for €3 million, completing the transaction through an asset purchase agreement. This acquisition reflects Relmada's mission to find solutions for refractory central nervous system diseases and its strategic goal of enhancing shareholder value by identifying and developing innovative compounds. Relmada will continue to evaluate additional products and strategic opportunities and expects to update investors on the next steps for Sepranolone's development later in 2025. With further clinical data support, if Sepranolone successfully transitions to later-stage clinical trials and ultimately receives approval, it is expected to become one of the first-line treatments for Tourette Syndrome, bringing new hope to patients. 20. Acelyrin Terminates Izokibep Program, Affibody Regains Drug Development Rights In 2021, Acelyrin acquired the license for izokibep with a $25 million upfront payment and committed to milestone payments of up to $280 million. Izokibep is an IL-17A inhibitor with a molecular weight only about one-eighth that of a typical antibody, exhibiting extremely high affinity for IL-17A and capable of specifically binding to both subunits of IL-17A as well as albumin in the serum. However, less than two years later, despite raising $540 million through an initial public offering to fund the late-stage trials of izokibep across multiple indications, Acelyrin ultimately decided to cease investment in the drug. Izokibep achieved the primary endpoint in a Phase III clinical trial for the treatment of hidradenitis suppurativa (HS), demonstrating a 33% reduction in abscesses and inflammatory nodules by 75% or more in patients, compared to 21% in the placebo group. Despite these positive results, Acelyrin chose to discontinue investment in this indication. Additionally, after achieving success in psoriatic arthritis (PsA), Acelyrin also withdrew its investment, retaining only uveitis as the final active development area for izokibep. However, the Phase IIb/III trial in this area failed to meet its primary and secondary endpoints. With Inmagene Biopharmaceuticals terminating the agreement covering Asian countries, including China and South Korea, the responsibility for izokibep will now fall entirely on Affibody in Sweden. Affibody's CEO, David Bejker, stated that he believes his company can better capitalize on the potential of izokibep than its former partner, particularly in the field of dermatology and for patients severely affected by hidradenitis suppurativa. This indicates Affibody's confidence in the potential of its product and its determination to regain control of the project. 21. Vanda Pharmaceuticals and AnaptysBio Reach Global Exclusive Licensing Agreement for IL-36R Antagonist Imsidolimab On February 3, 2025, Vanda Pharmaceuticals and AnaptysBio announced a global exclusive licensing agreement for imsidolimab, an IL-36R antagonist monoclonal antibody. Imsidolimab has completed two pivotal global Phase III clinical trials for generalized pustular psoriasis (GPP) - GEMINI-1 and GEMINI-2, demonstrating good safety and efficacy. This drug balances the inflammatory response by inhibiting the function of the IL-36 receptor, which is particularly important for GPP patients caused by mutations in the IL36RN gene. Under the terms of the agreement, Vanda will pay AnaptysBio a $10 million upfront payment and $5 million for existing drug supplies. Additionally, AnaptysBio will be eligible for up to $35 million in future regulatory approval and sales milestone payments, as well as a 10% royalty on global net sales. In this transaction, Vanda has obtained the global exclusive rights to develop, produce, and commercialize imsidolimab. These funds will support further research and development efforts to ensure that imsidolimab can reach the market as soon as possible. In the Phase III clinical trial of GEMINI-1, 53% of patients receiving a 750 mg intravenous injection of imsidolimab achieved a GPP Physician's Global Assessment (GPPPGA) score of 0/1 (skin almost or completely clear) at week 4, compared to only 13% in the placebo group (p=0.0131). In the subsequent GEMINI-2 trial, all patients in the maintenance dose treatment group maintained a GPPPGA score of 0/1 without relapse, while 63% of patients in the placebo group experienced disease worsening. These results indicate that imsidolimab has significant efficacy for GPP. Summary The clinical-stage drug investment, financing, and collaboration transactions in February 2025 revealed several trends: First, capital continues to be optimistic about innovative drugs, especially those with breakthrough therapeutic potential, and is willing to invest substantial funds to support research and development. Second, antibody-drug conjugates (ADCs) have become one of the key areas of collaboration, demonstrating the global popularity of this technology platform. Lastly, Chinese pharmaceutical companies are not only seeking growth opportunities in the domestic market but also actively expanding into international markets, accelerating the global layout and commercialization of new drugs through licensing deals and other means. These dynamics indicate that, despite the many challenges facing the pharmaceutical industry, companies are actively exploring new development paths through capital injection and technological collaboration, aiming to gain a favorable position in global competition. How to get the latest progress on drug deals? If you would like to access the latest transaction event information, you can click on the 'Deal' module from the homepage of the Synapse database. Within the Deal module, you can search for global pharmaceutical transaction information using labels such as Drugs, Organization, Target, Drug Type, Deal Date. Furthermore, you can obtain the original link to the transaction coverage by clicking on the "Deal Name." In the analysis view, you can see the most active assignors, assignees, popular targets, and other dimensions of analysis, as well as the distribution of research and development statuses at the time of the transaction, to help you better understand the search results. The Synapse database also supports the ability to view current transactions from the dimension of "drugs" (by selecting "drugs" from the "Adjust Dimension" dropdown menu above). Targeting transactions involving renowned pharmaceutical companies that are of interest to the industry, such as Merck, Roche, etc., Synapse has identified a group of "leading companies" through drugs that have achieved global sales exceeding 1 billion US dollars in 2022. Transactions involving drugs from these leading companies can be filtered by clicking on the "Leading Company" tag on the left-hand side. In addition to the drug transaction module, you can also view related transaction history on the drug detail page and the institution detail page. Click on the image below to explore new pharmaceutical funding transactions!

12 Feb 2025

·www.pharmaindustrial-india.com

Oramed to Accelerate Development and Commercialization of Oral Insulin

Oramed Pharmaceuticals has signed definitive agreements to spin off its Protein Oral Delivery (POD) technology into a newly formed joint venture, OraTech Pharmaceuticals Inc. (OraTech), with Hefei Tianhui Biotech Co., Ltd. (HTIT). This transaction is designed to accelerate the development and commercialization of Oramed's ORMD-0801 oral insulin and other POD™-based innovative oral drug delivery technologies, reinforcing Oramed's vision of revolutionizing diabetes and chronic disease treatments. As part of the transaction, Oramed will transfer its proprietary oral insulin and POD™ technology, along with other pipeline assets, into OraTech. The definitive agreements call for Oramed shareholders to receive a majority of Oramed's equity interest in the new entity, allowing them to directly participate in its future success. Additionally, under the agreements, Oramed and HTIT will contribute a combined USD 75 million in capital, some of which will be allocated for services rendered via a supply agreement. This financial backing will provide substantial resources for development, commercialization, and clinical advancement. "We are excited to launch OraTech, a company that brings together Oramed's technology and clinical development expertise with HTIT's state-of-the-art manufacturing capabilities. OraTech will be singularly focused on bringing oral insulin to market and unlocking the broader potential of oral drug delivery for additional therapeutic targets. With strong capital investment, an experienced leadership team, and world-class manufacturing support from HTIT, the company is uniquely positioned to advance its programs, including the planned reinitiation of a pivotal Phase 3 clinical trial in the United States," said Nadav Kidron, Chief Executive Officer of Oramed. OraTech will leverage HTIT's expertise in capsule production and cost-efficient manufacturing, ensuring a robust, reliable, and scalable supply chain to support clinical trials and commercialization efforts. With a clear focus on development and commercialization, strong financial backing, and a pipeline poised for clinical and regulatory advancements, OraTech is potentially set to redefine diabetes care and transform the future of oral biologics and chronic disease management.

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100 Deals associated with Insulin (Oramed)

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	NDA/BLA	China	Hefei Tianhui Incubator of Technologies Co., Ltd.	25 Apr 2023
Fibrosis	Phase 2	Israel	Oramed Ltd.	20 Sep 2018
Metabolic Dysfunction Associated Steatohepatitis	Phase 2	Israel	Oramed Ltd.	20 Sep 2018
Diabetes Mellitus, Type 1	Phase 2	Israel	Oramed Pharmaceuticals, Inc.	01 Jul 2008
Diabetes Mellitus	Phase 1	China	Hefei Haimaitongheng Biotechnology Co., Ltd.	03 Sep 2019

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04618744 (ORA-D-N02 \| Phase II Randomized, Placebo-controlled Feasibility Clinical Trial, CTgov)	Phase 2	Diabetes Mellitus, Type 2 \| Metabolic Dysfunction Associated Steatohepatitis	32	Placebo (Placebo)	kmmiyuaepa = ubqumtcfzs fagcrfjpbo (aiopelsumd, hmdblfkhrr - tippjmdoni) View more	-	07 Aug 2024
				Insulin (ORMD-0801 (Insulin) Capsule 8 mg BD)	kmmiyuaepa = uuphlyeoio fagcrfjpbo (aiopelsumd, bsedgtnwps - lxfduidjwx) View more
NCT04564846 (CTgov)	Phase 2	Diabetes Mellitus, Type 2	49	Placebo (Placebo)	uayjsxdsoh(wkoszpytuj) = wbopzljtym wridxbmlla (rpebijbdqn, 922.89) View more	-	07 May 2024
				ORMD-0801 (ORMD-0801)	uayjsxdsoh(wkoszpytuj) = sjsqwujnrs wridxbmlla (rpebijbdqn, 830.29) View more
NCT04616014 (CTgov)	Phase 2	Diabetes Mellitus, Type 2 \| Metabolic Dysfunction Associated Steatohepatitis	7	ORMD-0801 QD	nzhmyzsjlf = vtdwxebkrb npjczdsybr (ficqwzdwuw, qumlhzkutk - uorpzxfwex) View more	-	29 Mar 2024
NCT04618744 (Phase II Randomized, Placebo-controlled Feasibility Clinical Trial, Pubmed \| Gastro Hep Adv)	Phase 2	Diabetes Mellitus, Type 2 \| Metabolic Dysfunction Associated Steatohepatitis hemoglobin A1c \| alanine aminotransferase \| aspartate aminotransferase	-	Oral Insulin 8 mg	clnaxydetz(sixwsqxyha) = ixgmcvadfp vyylyogeww (edyojlxdqi ) View more	Positive	01 Jan 2024
				Placebo	clnaxydetz(sixwsqxyha) = mumqjacada vyylyogeww (edyojlxdqi ) View more
NCT04618744 (EASD2023)	Phase 2	Diabetes Mellitus, Type 2 \| Metabolic Dysfunction Associated Steatohepatitis insulin resistance \| inflammation	-	Oral insulin 8 mg	ufebauwlsu(qbhztbjswl) = zywaepcjmq eoshnfnzel (zqumbglzhc, 30.4) View more	Positive	04 Oct 2023
				Placebo	ufebauwlsu(qbhztbjswl) = xialqgsgbb eoshnfnzel (zqumbglzhc, 26.7) View more
NCT04618744 (ORA-D-N02, Corporate Publications) Manual	Phase 2	Metabolic Dysfunction Associated Steatohepatitis	32	ORMD-0801	sykhavjjjg(nspbfgfcrd) = Primary objective of safety met with no serious adverse events and no difference in the incidence rate of adverse events between ORMD-0801 and placebo. enajystijl (zjptfsjjlq )	Positive	17 Nov 2022
				Placebo
NCT04150107 (CTgov)	Phase 2	Diabetes Mellitus, Type 1	30	Placebo (Baseline)	fivihcqvwn(ylzcafoyun) = cvalpbyknu pnhopkbbdv (gdpzyvnlal, 2.489) View more	-	02 Jun 2022
				Insulin (Treatment A)	fivihcqvwn(ylzcafoyun) = gznwqtffjy pnhopkbbdv (gdpzyvnlal, 2.486) View more
NCT02496000 (Pubmed) Manual	Phase 2	Diabetes Mellitus, Type 2	188	ORMD-0801	gmmbaldsbj(ngsfptpvmb) = rumlgruzfw cpdyhcbljm (iyffmattnf, 23.5) View more	Positive	01 Nov 2021
				Placebo	gmmbaldsbj(ngsfptpvmb) = xgzzsxwygl cpdyhcbljm (iyffmattnf, 26.1) View more
NCT02653300 (CTgov)	Phase 2	Diabetes Mellitus, Type 2 \| Metabolic Dysfunction Associated Steatohepatitis \| Fibrosis	10	Oral Insulin	hollgfarms(ozscmpnhdr) = bhguiakcld tvbzdjnzmh (qtxhqwtqlj, 7.2) View more	-	23 Sep 2021
NCT02653300 (EASD2020)	Phase 2	Diabetes Mellitus, Type 2 \| Metabolic Dysfunction Associated Steatohepatitis	8	ORMD-0801	nsyszzfjbu(fnvjovuvpa) = The 12-week ORMD-0801 treatment proved safe and tolerable in all patients, with no serious or severe adverse events recorded throughout the study period. vnvyvpoizi (ygfvvpmkbf )	Positive	24 Sep 2020

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