Oramed Pharmaceuticals Inc (ORMP)

[aldo]

https://finance.yahoo.com/news/ormp-multiple-potential-applications-proprietary-122700708.html

[AJ Freely]

$ORMP - Signs Term Sheet with HTIT to Create a Joint Venture to Advance Oral Drug Delivery Technology Globally
👆Up 4.5% Pre-Market/ Current Price $3.52

[midastouch017]

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]

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
[e-mail]



Logo: https://mma.prnewswire.com/media/1724339/Oramed_Logo.jpg



Cision
Cision
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.

[AJ Freely]

$ORMP - 👆Up 4.8% Pre-Market/ Current Price $3.59
Signs Term Sheet with HTIT to Create a Joint Venture to Advance Oral Drug Delivery Technology Globally

[midastouch017]

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.

[starkd748]

Weeee uptrend confirmed

[midastouch017]

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]

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)

[starkd748]

Head n shoulders or blast off...Find out Monday

[starkd748]

Chart looks good

[midastouch017]

Looks like the Resurrection from the dead, or is it?
Hmmmm....

[midastouch017]

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)

[Amatuer17]

I agree - I will be happy if they are able to conduct the trial using Chinese protocol and make it a success in US as well

[midastouch017]

I am completely out of this stock

Me too, i just remotely follow the company out
of academic and personal interest.
(I would prefer an insulin pill to the Injection)

[Amatuer17]

That is good news for Oramed - not sure what they will get it - some royalty

Maybe they did not set up study parameters correctly. Now they have to start from scratch - maybe some BP will buy them

I am completely out of this stock and already booked a lot of losses

[midastouch017]

3.8200+0.9900 (+34.9823%)
As of 09:50AM EDT. Market open.
Volume 2,894,933
Avg. Volume 569,693

[midastouch017]

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.

[King Arthur]

The news from China that an oral insulin has reached the marketing approval stage, using oramed's technology, but oramed announced the phase III failure this year and stopped the oral insulin treatment for diabetes? Does anyone know the truth?

[starkd748]

Ahhh might be a good tick trade over sold on n the weekly

[starkd748]

I sold last week when I said the stochastic was overbought.....

[smokey1]

There's a lot of very good Israeli companies with great technology. Yesterday morning I mentioned DRIO which trading at $5.25 is now $6.02 up over 14%.
Don't give up just do your DD and a little good luck wouldn't hurt

[Fmello]

Any idea when they will be releasing the details of the failed phase 3 results?

Honestly, it still doesn't make sense to me since the phase 3 trial was essentially the same as the successful phase 2 trial, just twice as long with twice as many subjects.

[TheFinalCD]

4:44am

hmmm...I keep seeing that

[TheFinalCD]

sorry to hear, does ORMP not have other stuff in their pipeline??

[Amatuer17]

Just want to clarify - what I stated was my opinion based on the experience and an investment advice. I have been wrong more times than right

[humpback]

Thanks for the tip, just sold all shares. I think when we dipped a couple dollars last week, there was some insider trading going on.

[Amatuer17]

Check RDHL and BLRX - they became sub-Dollar stocks

Check CYDY - IPIX - they became penny stocks after the trial failures

[Amatuer17]

I sold all my stock - booked losses

In my view - the drug does not work. They can try to spin the wheel saying that it can be tested in NASH but NASH is such a long journey - company cannot survive

[humpback]

Is there any reason to hold on to what we have? Or is this company done with?

[humpback]

This is very painful

[ErnieBilco]

Israelis really can create losses for us who fall for their BS

Have yet to find a green one that actually does what they tout.

[smokey1]

DRIO will be the exception

[Amatuer17]

I have made loss on every Israeli stock - RDHL was the biggest
I will now avoid any Israeli companies for investment - I do not have luck with them

[midastouch017]

Same-same here.

Very disappointing for mankind, as well
as for my finances!

[Amatuer17]

That was brutal - lost significant money
Book the losses and move on
Another RDHL for me

[midastouch017]

So i suppose you sold out all your holdings
just prior to yesterdays news?

[starkd748]

Yes after the red candle spike....
https://www.tradingview.com/x/psNLrBER/
Stochastic overbought

[midastouch017]

Did your crystal ball forsee the
upcoming downfall of ORMP
I wonder?

[ranchhand71]

Looks like trial failed to reach end points. Disappointing.

[navyvet]

Yea surprised it didn't meet either wndpoint in any significant way. Thought for sure we would get at least a .5-.7% decrease in A1c. Well it's gonna be brutal guys.

[Fmello]

The results are out. It DID NOT meet the primary and secondary endpoints.

[navyvet]

It has been located in every quarterly and yearly financial report since 2019 or 2020. HTIT disputes terms of the agreement, and something like $5m of what's been received already is held in a special account pending any hopeful future resolution of the agreement. No updates on any resolution has been made in the 3 years though. At this point, China market really should be seen as a liability. The S. Korean deal is better in ways, however even that isn't with a large, established partner

[Fmello]

Yup but no response yet.

[ranchhand71]

Excellent question issue to pose to their IR guy. Have you tried?

[Fmello]

I was searching online and the last milestone payment that I could find was 3 million in 2019. The total amount that Oramed has received so far was 33 million out of their 50 million dollar deal.

So, is there any news why there has been a pause with the milestone payments?

[Amatuer17]

Any deal with Chinese co is risky - they will squeeze small co like Oramed - look at China trying to force PFE and MRK to reduce the price of Covid treatment

Alternatively they will copy the technology and create their own oral pills.

Also - if product is successful - the BP that buys this co will not be able to access China market due to the agreement - so they will not include China business in valuation

In summary - we have to watch the results and how it impacts US -Japan and Europe

[navyvet]

Nobody addresses the fact that we've had a disagreement with HTIT with no milestone payments for years, while the company stated we should expect China results before US trials, yet we still don't have any. Chances are, something is going on in China

[Fmello]

There are 139 million diabetics in China. Also, I found this in a 2016 World Health Organization story:

https://www.who.int/china/news/detail/06-04-2016-rate-of-diabetes-in-china-explosive-

"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."

I think our chances are even better to get approval in China due to the massive problem diabetes poses for their population.

[Amatuer17]

Next week is really mid-Jan as promised by management. So we could get results next week and if the results are good - we can fly.

Here is what PFE CEO said yesterday on JPM firechat on oral GLP-1 drug

———

In all the market research that we are doing, we see that there is a preference in the diabetic population for an oral compared to injectable. But when it comes to obese population, this is what really makes -- unlocks the market. It's significantly more important, the oral in the obese market than it is in the diabetic population. But even diabetic, there is a preference.
——-