Oramed Pharmaceuticals

Oramed Pharmaceuticals, Inc. engages in the provision of oral delivery solutions for drugs delivered via injection. It focuses on the research and development of pharmaceutical solutions, including an oral insulin capsule to be used for the treatment of individuals with diabetes, and the use of orally ingestible capsules or pills for delivery of other polypeptides. The company was founded by Nadav Kidron and Miriam Kidron on April 12, 2002 and is headquartered in New York, NY.

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Oramed Pharmaceuticals, Inc. engages in the provision of oral delivery solutions for drugs delivered via injection. It concentrates on the research and development of pharmaceutical solutions, including an oral insulin capsule to be used for the treatment of individuals with diabetes, and the use of orally ingestible capsules or pills for delivery of other polypeptides. The company was founded by Nadav Kidron and Miriam Kidron on April 12, 2002 and is headquartered in New York, NY.

Scilex Holding Co

NEW YORK , Oct. 7, 2024 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) ("Oramed"), a clinical-stage pharmaceutical company focused on the development of oral drug delivery platforms, today announced the execution of definitive agreements for the restructuring of a portion of its existing Senior Secured Promissory Note from Scilex Holding Company (Nasdaq: SCLX) ("Scilex"), a company focused on non-opioid pain management products. Key Highlights: Oramed, affiliates of Murchinson and 3i LP, entered into definitive agreements with Scilex for the purchase and sale of new tranche B senior secured convertible notes ("Notes") in the aggregate principal amount of $50 million (the "New Financing") and warrants to purchase up to 7,500,000 shares of the Company's common stock in the aggregate in a registered direct offering.

Oramed Pharmaceuticals Announces Restructuring of Scilex Holding Company Debt

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Stock Repurchase Program Scilex Senior Secured Note Phase 3 Oral Insulin Trial in US JV with Chinese Partner, HTIT NEW YORK , June 26, 2024 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP)  ("Oramed") ( www.oramed.com ), a clinical-stage pharmaceutical company focused on the development of oral drug delivery platforms, today issued a Letter to Shareholders from its Chief Executive Officer, Nadav Kidron. Dear Shareholders, In light of our recent announcement regarding Oramed's $20 million stock repurchase program, we believe this is an opportune moment to provide our shareholders with a comprehensive update on our activities and progress.

Oramed Letter to Shareholders

NEW YORK , June 26, 2024 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) (the "Company") (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery platforms, today announced today that its Board of Directors has authorized a common stock repurchase plan allowing for the buy-back of up to $20,000,000 in maximum value of its common stock through open market purchases, privately-negotiated transactions, or otherwise in compliance with Rule 10b-18 under the Securities Exchange Act of 1934, as amended, over the next 12 months (the "Stock Buy Back Program").     The manner, timing and number of shares purchased will be at the Company's discretion, depending on a number of factors, including price, general business and market conditions, and alternative investment opportunities.

Oramed Pharmaceuticals Inc. Announces the Buy-Back of its Common Stock

18-month loan with interest rate of SOFR plus 8.5% Oramed receives warrants to purchase up to 17 million shares of Scilex common stock The Senior Secured Note with Scilex replaces Oramed's previously announced Stock Purchase Agreement and DIP Term Loan with Sorrento Therapeutics NEW YORK , Sept. 21, 2023 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE:ORMP) today announced that on September 21, 2023, Oramed and Scilex Holding Company ("Scilex") entered into a Securities Purchase Agreement pursuant to which Scilex issued a Senior Secured Promissory Note (the "Note") to Oramed.

Oramed Announces $101,875,000 Short-Term Senior Secured Note Transaction with Scilex Holding Company

JV will have global marketing rights to oral drug delivery technology HTIT to invest $60 million, Oramed to invest $10 million into JV HTIT to provide a supply agreement for oral insulin capsule JV to advance registration of oral insulin in the United States and other countries NEW YORK , Aug. 2, 2023 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) (TASE: ORMP) (www.oramed.com) announced today that it has signed a non-binding term sheet with Hefei Tianhui Biotech Co., Ltd. ("HTIT") to establish a joint venture ("JV") based on Oramed's oral drug delivery technology.

Oramed Signs Term Sheet with HTIT to Create a Joint Venture to Advance Oral Drug Delivery Technology Globally

NEW YORK , June 20, 2023 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) (www.oramed.com), announced today that it has been selected to present an oral abstract presentation at the American Diabetes Association's 83rd Scientific Sessions, taking place between June 23-26, 2023 in San Diego, California. The presentation will include an overview of data from Oramed's Phase 2 oral insulin trial for the treatment of NASH as well as discuss how o ral i nsulin was found to potentially reduce l iver fibrosis and f at in patients with NASH and Type 2 Diabetes.

Oramed to Present at the 83rd American Diabetes Association Conference

NEW YORK , May 18, 2023 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) (www.oramed.com), announced today that Chief Scientific Officer Dr. Miriam Kidron will deliver an in-person presentation at the Novel Therapies for Type 2 Diabetes & Obesity Summit in Boston, MA, on May 31, 2023. The presentation will include an overview of Oramed's oral delivery technology as well as insights from the Company's recent Phase 3 oral insulin clinical trials.

Oramed to Present at Novel Therapies for Type 2 Diabetes & Obesity Summit

Oramed has completed an analysis of its U.S.-based Phase 3 oral insulin trial with significant lowering of A1C levels seen in patient subgroups NEW YORK , May 15, 2023 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) (www.oramed.com) announced today that Hefei Tianhui Biotechnology Co. Ltd. (HTIT), a strategic partner of Oramed, has successfully completed its Phase 3 trials of oral insulin in type 2 diabetes in China under a differentiated study protocol.

Oramed Announces that its Chinese Partner, HTIT, has Successfully Completed a Phase 3 Oral Insulin Clinical Trial and Submitted a Marketing Authorization Application in China

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NEW YORK , Feb. 9, 2023 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) (www.oramed.com), announced today that it continues to conduct a comprehensive analysis of the data from its discontinued Phase 3 oral insulin trials.  In addition, management and the Board of Directors are examining the Company's existing pipeline and conducting a comprehensive review of strategic alternatives focused on enhancing shareholder value.

Oramed Pharmaceuticals Issues Shareholder Update

The company's lead pipeline candidate is still being evaluated as a potential treatment for NASH after a major flop in treating type 2 diabetes.

Why Oramed Pharmaceuticals Stock Is Crashing Today

Oramed (NASDAQ: ORMP ) stock is falling hard on Thursday after releasing data from a Phase 3 clinical trial. This clinical trial saw Oramed testing the efficiency of ORMD-0801 in patients with Type 2 Diabetes at 26 weeks against those taking a placebo.

Why Is Oramed (ORMP) Stock Down 75% Today?

Shares of Oramed Pharmaceuticals Inc. ORMP, +5.78% plunged 72% in premarket trading on Thursday, the day after the company told investors its oral insulin medication did not meet the primary or secondary endpoints in a Phase 3 clinical trial. The randomized, double-blind, placebo-controlled trial compared Oramed's treatment to placebo to see if it improved glycemic control in patients with type 2 diabetes.

Oramed's oral insulin pill fails; stock is down 72%

NEW YORK , Jan. 11, 2023 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (Nasdaq/TASE: ORMP), a clinical-stage pharmaceutical company focused on the development of oral drug delivery platforms, announced today top-line results from its Phase 3 randomized, double-blind, placebo-controlled, multicenter clinical trial (ORA-D-013-1) comparing the efficacy of ORMD-0801 to placebo in patients with Type 2 Diabetes (T2D) at 26 weeks. ORA-D-013-1 enrolled 710 patients with T2D and inadequate glycemic control on two or three oral glucose-lowering agents.

Oramed Announces Top-line Results from Phase 3 Trial of ORMD-0801 for the Treatment of Type 2 Diabetes

NEW YORK , Jan. 4, 2023 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery platforms, today announced that the United States Patent and Trademark Office has granted the Company a patent titled "Methods and Compositions for Treating Diabetes."  The patent serves as an extension to a patent previously granted in May 2022 and addresses methods and compositions for treating diabetes mellitus through oral pharmaceutical compositions comprising insulin in combination with Glucagon-like Peptide 1 (GLP-1).

Oramed Granted U.S. Combination Therapy Patent for Oral GLP-1 & Insulin for the Treatment of Diabetes

Oramed achieved positive results from phase 2 study using ORMD-0801 for Type 2 Diabetes patients with NASH. Primary safety endpoint and secondary exploratory biomarker endpoints established proof of concept. Results from the phase 3 study using ORMD-0801 for the treatment of patients with Type 2 Diabetes are expected in January of 2023.

Oramed: NASH Biotech Play With Added Bonus

NEW YORK , Nov. 29, 2022 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, today announced that Diabetes, Obesity, and Metabolism, has published an original article titled: "Oral Insulin (ORMD-0801) in Type 2 Diabetes Mellitus: Dose-Finding 12-Week Randomized Placebo-Controlled Study," authored by Roy Eldor, MD PhD, Bruce H. Francis, MD, Alexander Fleming, MD, Joel Neutel, MD, Kenneth Homer, MS, Miriam Kidron, PhD, and Julio Rosenstock, MD.

Oramed Announces Publication of Oral Insulin Study in Peer-Reviewed Journal: Diabetes, Obesity, and Metabolism

- MEDICOX secures distribution right for ORAMED's oral insulin in South Korea after phase 3 of FDA approval - Contract scale up to 18 million dollars for developmental milestone and up to 15% royalty for sales - ORAMED says 1 in 7 Korean adults over 30 have diabetes and expects market potential SEOUL, South Korea , Nov. 18, 2022 /PRNewswire/ -- On 14th, MEDICOX (054180), listed on KOSDAQ, signed an exclusive distribution contract with an oral drug delivery platform developer, ORAMED Pharmaceuticals (hereinafter "ORAMED", Listed on NASDAQ) on the oral insulin license.  Signing the contract, MEDICOX secured an exclusive right to distribute the oral insulin in South Korea for 10 years after receiving approval from the Ministry of Food and Drug Safety on ORAMED's oral insulin candidate (ORMD-0801).

MEDICOX Signs Contract with ORAMED to Distribute Oral Insulin in South Korea

Medicox to Distribute Oramed's Oral Insulin in South Korea, if approved Oramed to Receive Up to $18 Million in Developmental Milestones Oramed to Receive up to 15% Royalties on Gross Sales Large Market Potential: 1 in 7 Koreans Over Age 30 Has Diabetes NEW YORK , Nov. 14, 2022 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (Nasdaq/TASE: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery platforms, today announced it has signed an exclusive commercial distribution agreement for the Republic of Korea (formerly South Korea) with Medicox Co., Ltd., an emerging biotech company with an excellent consortium of proven partnerships in the Republic of Korea.

Oramed Signs Definitive Deal with Medicox to Commercialize Oral Insulin in South Korea

NEW YORK , Nov. 10, 2022 /PRNewswire/ -- Oramed Pharmaceuticals Inc. ("Oramed" or the "Company") (Nasdaq: ORMP) (TASE: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery platforms, today reported its financial results for the quarter ended September 30, 2022.   "We are pleased to share our quarterly report for the third quarter of 2022.

Oramed Reports Third Quarter 2022 Financial Results

Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery platforms, today announced that it will host a data presentation on newly released safety and efficacy data from the Phase 2 trial of its oral insulin candidate (ORMD-0801) to reduce liver fat content in Type 2 Diabetes ("T2D") patients with non-alcoholic steatohepatitis ("NASH") on Thursday, November 17, 2022, at 11:00 a.m. Eastern Standard Time.

Oramed to Host Webinar Highlighting Detailed Safety and Efficacy Data from Its Positive Phase 2 Clinical Trial of ORMD-0801 for NASH

Primary and secondary endpoints of safety and immunogenicity met Oral vaccine elicited a potentially protective IgG response with significant seroconversion from baseline Trial shows proof of concept for oral delivery of vaccines using Oravax technology NEW YORK , Oct. 7, 2022 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery platforms, today announced that its subsidiary, Oravax Medical Inc., reported positive preliminary data from its Phase 1 trial of an oral Covid-19 vaccine candidate. Preliminary Phase 1 trial results from the first cohort include: Significant antibody response (2-6 fold over baseline) as measured by multiple markers of immune response to VLP vaccine antigens observed in majority of the patients dosed No safety issues observed, including mild symptoms Oravax Medical is a clinical-stage vaccine company developing oral vaccines that combine Oramed Pharmaceuticals' POD™ technology with Premas Biotech's D-Crypt™ Platform.

Oramed Subsidiary Oravax Reports Positive Preliminary Phase 1 Data for its Oral Covid-19 Vaccine

Results from Oramed Pharmaceuticals's first phase 3 study ORA-D-013-1, using ORMD-0801 for the treatment of patients with Type 2 Diabetes, is expected January 2023. Results from the ongoing Cohorts A and B, using Oravax for Covid-19, are going to be read out Q3 and Q4 of 2022 respectively.

Oramed: Oral Insulin For Type 2 Diabetes May Become A Reality

Primary endpoint met: ORMD-0801 was safe and well tolerated Secondary endpoint met: ORMD-0801 showed clinically meaningful reduction of liver fat from baseline at 12 weeks Strong evidence for treatment of NASH using Oramed's oral insulin NEW YORK , Sept. 13, 2022 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery platforms, announced today positive Phase 2 results from its double-blind, fully randomized, placebo-controlled, multicenter trial to assess the safety and efficacy of its oral insulin candidate (ORMD-0801), to reduce liver fat content in Type 2 Diabetes ("T2D") patients with non-alcoholic steatohepatitis ("NASH").

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