eyeownu
5 months ago
As of the current market, there are a few widely available oral GLP-1 analogs for the treatment of type 2 diabetes. One notable oral GLP-1 analog that has been approved and is available on the market is:
Rybelsus (semaglutide): This is the first and currently the only oral GLP-1 receptor agonist approved for the treatment of type 2 diabetes. It is produced by Novo Nordisk and is available in different dosage strengths.
Note: While injectable GLP-1 analogs are more common and include well-known options like Ozempic (semaglutide), Trulicity (dulaglutide), Victoza (liraglutide), and Byetta (exenatide), the oral formulations are still relatively new and limited in variety. The introduction of oral GLP-1 analogs, such as Rybelsus, represents a significant advancement in the field, providing a non-injectable option for patients.
eyeownu
5 months ago
Financial Snapshot of Oramed Pharmaceuticals Inc.
Cash on Hand:
As of June 30, 2022, Oramed Pharmaceuticals Inc. had $29.9 million in cash and cash equivalents, and $97.4 million in short-term deposits, totaling $127.3 million in liquid assets.
Revenue vs. Expenses:
For the quarter ending June 30, 2022, Oramed generated $674,000 in revenue. However, they reported significant expenses, including $9.2 million in research and development and $2.5 million in general and administrative expenses. This resulted in a net operating loss of $11.4 million and a net loss attributable to shareholders of $10.5 million.
Cash Burn Rate:
Based on the net loss, the company's cash burn rate was approximately $10.5 million per quarter.
Largest Expense:
The largest expense category was research and development, totaling $9.2 million for the quarter.
Shares Outstanding:
As of June 30, 2022, the company had 38,564,016 shares of common stock outstanding.
Insider Share Ownership and Transactions:
Detailed information on insider share ownership and recent transactions was not specifically detailed in the accessible filings. For more granular details, it is recommended to review the most recent Form 4 filings.
Senior Note Holders:
Oramed holds a Senior Secured Promissory Note issued by Scilex Holding Company, valued at $101.875 million, with a due date 18 months from issuance (September 21, 2023). Payments made by Scilex so far total $40 million.
Warrants and Convertible Securities:
Oramed possesses various warrants including Penny Warrants and Transferred Warrants. The Penny Warrants are exercisable at various dates in 2024 and 2025, contingent on the repayment of the Senior Secured Note. The Transferred Warrants have an exercise price of $11.50 per share and expire on November 10, 2027.
Shelf Registration and Capital Raise:
The company has an active shelf registration statement on Form S-3, allowing the issuance of securities up to $100 million. As of the latest filings, approximately $26.3 million in shares were sold under the Cantor Equity Distribution Agreement.
Nasdaq Listing Compliance:
There were no recent notifications or compliance issues with Nasdaq's listing requirements reported in the filings.
Overall Financial Health Assessment
Oramed Pharmaceuticals Inc. maintains a strong liquidity position with substantial cash reserves and no reported long-term debt. However, the company is heavily investing in research and development, leading to significant operating losses. The existence of the Senior Secured Promissory Note and related warrants reflects strategic financial maneuvers to secure funding and potential upside. Investors should closely monitor ongoing financial performance and capital allocation strategies.
midastouch017
1 year ago
Oramed to form joint venture with China-based Hefei Tianhui Biotech
Aug. 02, 2023 8:30 AM ETOramed Pharmaceuticals Inc. (ORMP)
By: Dulan Lokuwithana, SA News Editor
Oramed Pharmaceuticals (NASDAQ:ORMP) gained ~5% pre-market Wednesday after announcing a non-binding deal with China-based Hefei Tianhui Biotechnology Co., Ltd. to establish a joint venture focused on the company’s oral drug delivery technology.
The formation of the JV is subject to the completion of a binding agreement, the New York-based drug developer said, adding that both companies will initially hold equal shares in the new entity.
The joint venture will be responsible for the global development, marketing, and commercialization of drugs focused on Oramed's oral insulin and POD technology as well as its other experimental drugs.
The new entity is expected to begin a Phase 3 oral insulin trial in the U.S.
Initially, Oramed (ORMP) and Hefei Tianhui will invest $60M and $10M for the project, respectively, and both companies will have equal representation on the JV’s director board.
midastouch017
1 year ago
Oramed Signs Term Sheet with HTIT to Create a Joint Venture to Advance Oral Drug Delivery Technology Globally
https://finance.yahoo.com/news/oramed-signs-term-sheet-htit-114500114.html
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. The proposed JV would focus on the development and worldwide commercialization of innovative products based on Oramed's oral insulin and POD™ (Protein Oral Delivery) pipeline and HTIT's manufacturing capabilities and technologies. The JV is subject to the execution of a binding definitive agreement.
"We are thrilled to further our relationship with HTIT, expanding the reach of our oral drug delivery technology to a global market," said Oramed Chief Executive Officer, Nadav Kidron. "HTIT has successfully completed a Phase 3 oral insulin trial and submitted a New Drug Application ("NDA") to the National Medical Products Administration ("NMPA"), with marketing approval currently pending in China. HTIT has state-of-the-art facilities, manufacturing capabilities and the know-how needed to produce oral insulin on an international scale. This JV is a true opportunity to leverage our strengths as well as those of our partners to fast-track our pipeline towards commercialization."
Scope of the Joint Venture
The JV would be responsible for developing, marketing and commercializing drug products globally, focusing on Oramed's oral insulin and POD™ technology, as well as other assets in the Oramed pipeline. The parties intend for the JV to initiate a Phase 3 oral insulin trial in the United States.
Structure of Joint Venture
Oramed and HTIT would initially hold equal shares in the JV, with each owning 50% of the equity. The Board of Directors would initially consist of equal representation from HTIT and Oramed, ensuring that both parties have an equal say in decision-making. As part of the Joint Venture, HTIT will make an initial investment of $60 million, while Oramed will invest $10 million.
About Oramed Pharmaceuticals
Oramed Pharmaceuticals (Nasdaq/TASE: ORMP) is a platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. The company's novel Protein Oral Delivery (POD™) technology is designed to protect drug integrity and increase absorption. Oramed has offices in the United States and Israel. For more information, please visit www.oramed.com.
About HTIT
Hefei Tianhui Biotechnology Co., Ltd. (HTIT) has a state-of-the-art oral insulin manufacturing facility in Hefei, China. HTIT is a high-tech company focused on biopharmaceutical product manufacturing and R&D with an emphasis on the oral delivery of therapeutic macromolecules.
Forward-looking statements: This press release contains forward-looking statements. For example, we are using forward-looking statements when we discuss potential marketing approval by HTIT and commercialization in China, the potential to enter into definitive documentation with respect to the JV, which is currently still under negotiation according to the understanding set forth in the non-binding term sheet, the potential safety and efficacy of oral insulin and the potential of Oramed and/or the JV to move forward with its oral insulin product and fast-track its pipeline towards commercialization. These forward-looking statements are based on the current expectations of the management of Oramed only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements, including the ability of the parties to reach agreement on a definitive JV agreement and the transactions contemplated by the term sheet, which may not occur; Oramed's process to evaluate strategic options; the terms, timing, structure, benefits and costs of any strategic transaction and whether any transaction will be consummated at all; the impact of any strategic transaction on Oramed; the outcomes of any litigation, regulatory proceedings, inquiries or investigations to which Oramed may be subject; the ability to obtain financing or third-party approvals as needed; our ability to achieve the intended benefits of our strategic initiatives; the risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval or patent protection for our product candidates; competition from other pharmaceutical or biotechnology companies; and our ability to obtain additional funding required to conduct our research, development and commercialization activities. In addition, the following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; delays or obstacles in launching our clinical trials; changes in legislation; inability to timely develop and introduce new technologies, products and applications; lack of validation of our technology as we progress further and lack of acceptance of our methods by the scientific community; inability to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties that may develop with our process; greater cost of final product than anticipated; loss of market share and pressure on pricing resulting from competition; laboratory results that do not translate to equally good results in real settings; our patents may not be sufficient; that products may harm recipients; and other factors discussed in the "Risk Factors" section of Oramed's most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, which are on file with the Securities and Exchange Commission and in other filings that Oramed makes with the Securities and Exchange Commission in the future. All of these factors could cause the actual results or performance of Oramed to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Oramed undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
Company Contact:
Zach Herschfus
+1-844-9-ORAMED
zach@oramed.com
Logo: https://mma.prnewswire.com/media/1724339/Oramed_Logo.jpg
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SOURCE Oramed Pharmaceuticals Inc.
midastouch017
2 years ago
Oramed to Present at the 83rd American Diabetes Association Conference
New York, NY June 20, 2023 — Oramed Pharmaceuticals Inc. (Nasdaq/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 oral insulin was found to potentially reduce liver fibrosis and fat in patients with NASH and Type 2 Diabetes.
Presentation Details:
Abstract title: Oral Insulin Alleviates Liver Fibrosis and Reduces Fat in Patients with NASH and Type 2 Diabetes—Results of Phase II Clinical Trial
Session: Metabolic Liver Disease—From Bench to Bedside
Date: Friday, June 23, 2023
Time: 3:15pm PST
The oral presentation will be delivered in-person at the San Diego Convention Center in San Diego, California and will also be published on the journal Diabetes® website.
midastouch017
2 years ago
ORMP: Advancing Development Efforts in China
https://finance.yahoo.com/news/ormp-advancing-development-efforts-china-150600140.html
By M. Marin
Licensing deal – potential royalty payments if product is commercialized in China …
Earlier this month, Oramed Pharmaceuticals’ (NASDAQ:ORMP) partner in China, Hefei Tianhui Biotechnology Co. (HTIT), completed a Phase 3 oral insulin clinical trial in China and, based on the results, submitted a marketing authorization application to China’s regulatory body, the National Medical Products Administration. The company believes the completion of the Phase 3 trials of oral insulin in type 2 diabetes (T2D) in China, which were conducted under a differentiated study protocol, and application submission furthers the partners’ ability to commercialize ORMD-0801 in China.
The company’s licensing agreement with HTIT included milestone payments to ORMP and potential royalty revenue when / if ORMD-0801 is commercialized in China, where ORMP believes there is significant opportunities for an oral insulin treatment. More than 10% of the adult population in China has diabetes, according to the World Health Organization (WHO), which noted in 2016 that:
“In 1980, less than 5% of Chinese men had diabetes. Now, more than 10% do. This increase has been largely driven by unhealthy lifestyles – diets that are too high in sugar and fat, and people not getting enough physical activity… Even more startling is the fact that almost half of all adults in China – close to 500 million people – have prediabetes. Not only does this pose a risk factor for developing Type 2 diabetes, but also for other conditions such as cardiovascular disease.”
Company encouraged by analysis of U.S. ORA-D-013-1 data …
Moreover, a recently completed analysis of the data from the U.S.-based Phase 3 trial for the treatment of T2D found statistically significant lowering of A1C levels seen in patient subgroups. Analysis of the data found that subpopulations of patients with pooled specific parameters, such as body mass index (BMI), baseline HbA1c, age, gender and body weight, responded well to oral insulin. Certain population subsets displayed a greater than 1% placebo adjusted, reduction in HbA1c that the company has characterized as statistically significant. “Higher A1C levels are linked to diabetes complications,” according to the CDC (Centers for Disease Control). Based on the analysis, the company believes that patients over age 54 with BMI of less than 31 tend to have the largest reduction in A1c p-value lower than 0.002, as illustrated below where the bright yellowish colors represent large reduction in A1C for the treatment patients versus placebo, according to company.
… with multiple program / development efforts underway …
Oramed has multiple clinical development programs underway. ORMD-0801 is being studied for the treatment of T2D and in NASH. ORMP is also leveraging its technology for an orally ingestible glucagon-like peptide-1 (GLP-1) capsule. ORMD-0901 is an orally ingestible exenatide (GLP-1 analog) capsule designed to aid in the balance of blood-sugar levels and also to decrease appetite. ORMD-0901 is designed for the treatment of obesity in patients with diabetes. Obesity is a growing problem worldwide. In addition, through a JV, the company is developing an orally administered vaccine for the COVID-19 virus. We believe Oramed’s multiple clinical development programs underscore the potential versatility of the company's oral protein delivery platform technology.
midastouch017
2 years ago
Oramed to Present at Novel Therapies for Type 2 Diabetes & Obesity Summit
https://finance.yahoo.com/news/oramed-present-novel-therapies-type-115500024.html
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.
Presentation Details:
Novel Therapies for Type 2 Diabetes & Obesity Summit
Date: Wednesday, May 31, 2023
Time: 1:30 p.m. E.T.
Location: Hyatt Regency Boston, Boston, MA
For more information regarding the summit and the presentation, please visit the Summit's website: Home - Novel Therapies for Type 2 Diabetes & Obesity Summit 2023 (t2d-obesity-summit.com)
midastouch017
2 years ago
Oramed to Present at Novel Therapies for Type 2 Diabetes & Obesity Summit
https://finance.yahoo.com/news/oramed-present-novel-therapies-type-115500024.html
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.
Presentation Details:
Novel Therapies for Type 2 Diabetes & Obesity Summit
Date: Wednesday, May 31, 2023
Time: 1:30 p.m. E.T.
Location: Hyatt Regency Boston, Boston, MA
For more information regarding the summit and the presentation, please visit the Summit's website: Home - Novel Therapies for Type 2 Diabetes & Obesity Summit 2023 (t2d-obesity-summit.com)
midastouch017
2 years ago
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
https://finance.yahoo.com/news/oramed-announces-chinese-partner-htit-130500265.html
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. HTIT is now moving toward regulatory approval and has submitted the data to the National Medical Products Administration (NMPA, formerly the CFDA).
Oramed has recently completed an analysis of the data from its U.S.-based, Phase 3 trial, ORA-D-013-1, for the treatment of type 2 diabetes. This analysis found that subpopulations of patients with pooled specific parameters, such as body mass index (BMI), baseline HbA1c, age, gender and body weight, responded well to oral insulin. These subsets exhibited an over 1% placebo adjusted, statistically significant, reduction in HbA1c. The significant impact of baseline BMI on the responder group within the U.S. Phase 3 trial aligns with the positive data from the HTIT trial in China. The U.S. subpopulation and the Chinese general trial population shared a very similar baseline BMI.
"We are excited by our partner, HTIT's, success and share in their excitement as they move one step closer to commercialization in China," said Oramed Chief Executive Officer, Nadav Kidron. "Additionally, we are encouraged by the review of our Phase 3 data which found a strong correlation between certain parameters and the oral insulin's efficacy. Based on these findings, Oramed is exploring ways to move forward with its oral insulin product," Mr. Kidron added.
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