US Market News
2日前
Oramed Releases Letter to Shareholders, Highlighting Russell 2000/3000 Index Inclusion, Scilex Loan Repayment, Strategic Portfolio Appreciation, and a Strengthened Balance SheetJune 25, 2026 11:35 AM
PR Newswire (US) Significant Appreciation in Alpha Tau (NASDAQ: DRTS) Position (up ~$128 Million)Scilex (NASDAQ: SCLX) Loan Substantially RepaidTotal Cash and Assets Build to Approximately $270 Million (as of March 31, 2026, after the $10.5 million dividend paid in January 2026)Oramed to Join the Russell 2000 and Russell 3000 Indexes this weekNEW YORK, June 25, 2026 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) (TASE: ORMP) ("Oramed" or the "Company" or "we"), a diversified operating company, today issued the following Letter to Shareholders from its Chief Executive Officer, Nadav Kidron. The letter highlights the Company's addition to the Russell 2000 and Russell 3000 indexes, the substantial repayment of its Scilex loan, and a strengthened balance sheet of approximately $270 million in total cash and assets, as of March 31, 2026 (unaudited). Dear Shareholders,I am pleased to update you on the significant developments across Oramed's operations and strategic initiatives since our last letter. We have continued to advance our diversified strategy, pairing disciplined capital deployment across the biomedical and broader investment landscape with active, hands-on engagement in the companies in which we invest.Following the transfer of our oral drug-delivery platform and refined oral insulin program to Lifeward, Oramed is now a diversified operating company. We leverage our deep industry relationships, regulatory expertise, and operational experience to identify, structure, and help unlock value across a diversified strategic portfolio, while maintaining a strong balance sheet and a continued commitment to rewarding shareholders.Strategic TransactionsAlpha Tau Medical Ltd. - Invested: ~$38.2M
- Current Value: ~$167M (incl. warrants)Alpha Tau (NASDAQ: DRTS) is pioneering Alpha DaRT™, a breakthrough alpha-radiation therapy that eradicates solid tumors from within while sparing surrounding healthy tissue.Alpha Tau remains what we believe to be a compelling opportunity that has delivered a series of clinical and commercial milestones, with what we view as significant potential upside. Highlights include:Landmark U.S. commercialization partnership with Tolmar (June 2026). Alpha Tau granted Tolmar exclusive U.S. rights to commercialize Alpha DaRT in prostate cancer — a powerful validation of the platform in a market of more than 330,000 new U.S. cases a year. The deal delivers a $20 million equity investment at $12/share (a 25% premium to VWAP), $15 million in U.S. manufacturing, up to $161.5 million in milestones, and an option to expand into bladder cancer. Critically, Alpha Tau will supply Alpha DaRT to Tolmar at 60% of net sales, retaining the majority of the economics on every treatment sold in the U.S. prostate indication. To put that in perspective, at an estimated $60,000 to $120,000 per treatment, capturing even 30% could unlock a U.S. market opportunity exceeding $2 billion every year in this single indication.Standout pancreatic-cancer survival data at ASCO 2026 (June 2026). According to Alpha Tau's public disclosures, pooled Phase I/II results showed median overall survival of roughly 11 months, compared to a reported four-to-six-month historical benchmark for second-line metastatic patients, with a clean safety profile and no treatment-related deaths.FDA clearance to complete the REGAIN glioblastoma trial (June 2026). According to Alpha Tau's public disclosures, the FDA cleared Alpha Tau to finish enrollment and add two U.S. academic sites, with early data from the first three patients showing 100% local disease control and a 67% complete response rate. Alpha DaRT holds FDA Breakthrough Device Designation in this indication.Looking ahead, based on its public disclosures, Alpha Tau is advancing five concurrent FDA-cleared U.S. trials, moving toward a PMA submission for its pivotal skin-cancer program, building on its Japanese marketing approval earlier this year for Alpha DaRT in head and neck cancer — the platform's first regulatory approval outside Israel — and initiating its U.S. prostate-cancer program with Tolmar.Scilex Holding - Invested: $99.5M
- Recouped to Date: ~$118M | Outstanding: ~$43M
- Royalties (net sales): 4%, minimum ~$1.6M/yearScilex Holding Company (NASDAQ: SCLX) - In 2023, we provided Scilex with an approximately $99.5 million secured loan. Since then, through a combination of principal and interest payments, warrants, and royalties, we have recouped approximately $118 million, and we expect to receive approximately $43 million by October 2026. All told, we anticipate recovering roughly $161 million on our original $99.5 million loan, representing a substantial return on the capital we deployed.We also retain a 4% royalty on worldwide net sales of ZTlido and related products for another eight years, preserving long-dated upside even after the loan is repaid.LifewardIn March 2026 we completed a transformative transaction with Lifeward Ltd. (NASDAQ: LFWD), a revenue-generating medical robotics company behind the ReWalk Personal Exoskeleton and AlterG anti-gravity systems.Lifeward's first-quarter 2026 results, reported in May 2026, reflected encouraging operational progress: it cut quarterly operating cash burn by roughly 33% year-over-year and grew ReWalk Personal exoskeleton sales by 11%. We remain confident in Lifeward's trajectory and committed to supporting its path to profitability.Additional Portfolio HoldingsBeyond these core positions, we hold a diversified portfolio of holdings, each selected for its potential to generate substantial returns while complementing our competencies, including Nano Dimension, BioXcel Therapeutics, Diasome Pharmaceuticals, Hopec Pharma, and Ninamed, alongside secured loans yielding real estate investments. This approach is already delivering realized gains: we recently exited Pelthos Therapeutics at $3.6 million, having invested $1.5 million just seven months earlier.Russell IndexesAs announced on June 17, 2026, Oramed is expected to be added to the Russell 2000 and Russell 3000 indexes in connection with FTSE Russell's 2026 annual reconstitution, effective at the U.S. market open on June 29, 2026. We expect this milestone to enhance Oramed's visibility within the investment community, broaden our shareholder base, and support trading liquidity in our common stock over time.In ConclusionWe believe the numbers speak for themselves. We have transformed our oral insulin program from a stand-alone clinical effort into a substantial equity and economic interest in a revenue-generating partner; we have substantially recouped our Scilex loan, while retaining long-dated royalty upside; and we have built a diversified portfolio anchored by a significant and highly appreciated position in Alpha Tau, alongside strategic holdings in Lifeward and others. Our anticipated inclusion in the Russell 2000 and Russell 3000 indexes is expected to broaden our shareholder base and improve liquidity, and our balance sheet remains strong, with total cash and assets of approximately $270 million as of March 31, 2026 (unaudited).We believe this combination of disciplined capital deployment, active strategic portfolio engagement, and a strong balance sheet positions Oramed to continue pursuing meaningful, durable value for shareholders. Thank you for your continued support. We look forward to updating you on our progress in the coming quarters.Sincerely,Nadav Kidron
President and Chief Executive Officer
Oramed Pharmaceuticals Inc.About Oramed PharmaceuticalsOramed Pharmaceuticals Inc. (Nasdaq/TASE: ORMP) is a diversified operating company that deploys capital across the biomedical and broader investment landscape, leveraging deep industry relationships, regulatory expertise, and operational experience to build and actively support a diversified portfolio of holdings. For more information, please visit https://oramed.com/.Forward-looking statements:This letter contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates," "may," "will," "could," "should," "potential," and similar expressions are intended to identify forward-looking statements. For example, we are using forward-looking statements when we discuss the expected benefits of, and value to be realized from, the Lifeward transaction, including the convertible notes, equity, warrants, and revenue-sharing payments; expected returns from our investment portfolio, including Scilex, Alpha Tau, Nano Dimension, and others; statements regarding Alpha Tau's clinical trials, regulatory progress, the Tolmar collaboration, and potential commercial approvals, which are based solely on Alpha Tau's public disclosures and over which we have no control; our real estate and other investments; our expected inclusion in the Russell indexes and expected benefits therefrom; our share-repurchase plans; current portfolio valuations, which are based on market prices that fluctuate and may decline; the expected timing and amount of remaining Scilex loan repayments; and our ability to create shareholder value through our diversified approach. These statements are based on the current expectations of management only and are subject to a number of factors and uncertainties, including risks related to clinical trials and product development; regulatory approval; competition; market volatility affecting our investment portfolio and the valuations described herein; our ability to realize expected returns from Scilex, Lifeward, and other investments; and our ability to complete the expected index inclusion and additional financings; and general economic, geopolitical, and market conditions, that could cause actual results to differ materially from those described in such forward-looking statements. Inclusion in any index is determined by FTSE Russell and is not final until the reconstitution becomes effective.A discussion of these and other factors with respect to the Company is set forth in the Company's most recent Annual Report on Form 10-K and subsequent reports on Form 10-Q filed with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and the Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.Company Contact:+1-844-9-ORAMED
ir@oramed.comLogo: https://mma.prnewswire.com/media/1724339/Oramed_Logo.jpg View original content:https://www.prnewswire.com/news-releases/oramed-releases-letter-to-shareholders-highlighting-russell-20003000-index-inclusion-scilex-loan-repayment-strategic-portfolio-appreciation-and-a-strengthened-balance-sheet-302810903.htmlSOURCE Oramed Pharmaceuticals Inc. Original: Oramed Releases Letter to Shareholders, Highlighting Russell 2000/3000 Index Inclusion, Scilex Loan Repayment, Strategic Portfolio Appreciation, and a Strengthened Balance Sheet
US Market News
1週前
Oramed Pharmaceuticals to Join Russell 2000® and Russell 3000® IndexesJune 17, 2026 8:55 AM
PR Newswire (US) NEW YORK, June 17, 2026 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) (TASE: ORMP) (www.oramed.com), announced today that it is set to join the U.S. small cap Russell 2000® and broad-market Russell 3000® Index at the conclusion of the 2026 Russell indexes semi-annual reconstitution. The 2026 Russell 2000 and Russell 3000 reconstitution becomes final after the close of US markets on Friday, June 26, and becomes effective for trading at the market open on Monday, June 29, according to a preliminary list of additions posted by FTSE Russell on May 22, 2026. Semi-annual Russell indexes reconstitution captures the 4,000 largest U.S. stocks as of April 30, 2026, ranking them by total market capitalization. Membership in the U.S. all-cap Russell 3000® Index, which remains in place for one year, means automatic inclusion in the large-cap Russell 1000® Index or small-cap Russell 2000® Index as well as the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $12.2 trillion in assets are benchmarked against Russell's U.S. indexes. Russell indexes are part of FTSE Russell, a leading global index provider.About Oramed PharmaceuticalsOramed Pharmaceuticals Inc. (Nasdaq/TASE: ORMP) is a diversified operating company that deploys capital across the biomedical and broader investment landscape, leveraging deep industry relationships, regulatory expertise, and operational experience to build and actively support a diversified portfolio of holdings. For more information, please visit https://oramed.com/.About FTSE Russell: FTSE Russell is a global index leader that provides innovative benchmarking, analytics and data solutions for investors worldwide. FTSE Russell calculates thousands of indexes that measure and benchmark markets and asset classes in more than 70 countries, covering 98% of the investable market globally.FTSE Russell index expertise and products are used extensively by institutional and retail investors globally. Approximately $20 trillion is currently benchmarked to FTSE Russell indexes. For over 30 years, leading asset owners, asset managers, ETF providers and investment banks have chosen FTSE Russell indexes to benchmark their investment performance and create ETFs, structured products and index-based derivatives.A core set of universal principles guides FTSE Russell index design and management: a transparent rules-based methodology is informed by independent committees of leading market participants. FTSE Russell is focused on applying the highest industry standards in index design and governance and embraces the IOSCO Principles. FTSE Russell is also focused on index innovation and customer partnerships as it seeks to enhance the breadth, depth and reach of its offering.FTSE Russell is wholly owned by London Stock Exchange Group.For more information on the Russell 3000® Index and the Russell indexes reconstitution, go to the "Russell Reconstitution" section on the FTSE Russell website. For more information, visit www.ftserussell.com.Forward-looking statements: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. For example, we are using forward-looking statements when we discuss our business strategy; the acquisition, operation, and growth of companies we invest in; clinical development and regulatory initiatives; commercialization activities; capital markets and financing activities; strategic transactions; product development programs; technologies; and potential future opportunities. In addition, historic results of scientific research, clinical trials, investments, strategic transactions or other business activities do not guarantee that future results will be identical or even similar. 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 risks and uncertainties related to our ability to obtain additional funding, complete strategic transactions, and deploy capital effectively; our ability to identify, acquire, integrate, and successfully operate companies we invest in; our ability to recruit, retain, and oversee qualified management teams at such companies; the success of clinical development, regulatory, commercialization, and business development strategies 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; our ability to obtain additional funding required to conduct our research, development and commercialization activities; and risks related to our investment portfolio, including fluctuations in the value of public and private investments, the performance of portfolio companies, royalty-generating assets and other investment holdings. In addition, the following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: inability to identify, complete, or realize anticipated benefits from strategic investments, acquisitions, dispositions, financings or other transactions; concentration risk arising from significant positions in a limited number of investments or industries; changes in technology, market conditions, healthcare industry trends and capital markets; delays or obstacles in clinical development, regulatory review, or strategic initiatives inability to timely develop and introduce new technologies, products, applications or investment opportunities; adverse developments affecting portfolio companies, including operational, financial, regulatory, clinical, or commercial setbacks; unforeseen scientific difficulties that may develop with our process; loss of market share and pressure on pricing resulting from competition; risks relating to intellectual property protection and enforcement; and adverse developments affecting portfolio companies, investments, licensing arrangements, royalty interests, or strategic counterparties;, all of which 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. For a more detailed description of the risks and uncertainties affecting Oramed, reference is made to Oramed's reports filed from time to time with the Securities and Exchange Commission.Company Contact+1-844-9-ORAMED
estee@oramed.comLogo - https://mma.prnewswire.com/media/1724339/Oramed_Logo.jpg View original content:https://www.prnewswire.com/news-releases/oramed-pharmaceuticals-to-join-russell-2000-and-russell-3000-indexes-302803049.htmlSOURCE Oramed Pharmaceuticals Inc. Original: Oramed Pharmaceuticals to Join Russell 2000® and Russell 3000® Indexes
eyeownu
2年前
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
3年前
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
Cision
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View original content:https://www.prnewswire.com/news-releases/oramed-signs-term-sheet-with-htit-to-create-a-joint-venture-to-advance-oral-drug-delivery-technology-globally-301891452.html
SOURCE Oramed Pharmaceuticals Inc.
midastouch017
3年前
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
3年前
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.