Oramed Pharmaceuticals Inc (ORMP)

[Fmello]

Yup, that's why the shorts are going to be fighting against the longs to try and manipulate the stock price.

[Sierra20]

Nice top line results should be coming out soon

[starkd748]

Extension and retracement..A B c triangle, 5 counts 9n Elliot wave

[Lwrnc2052]

Do you use fibonacci extensions?

[Fmello]

My guess is shorters trying to freak out investors to panic sell. Looks more likely that investors will buy on the dip.

[starkd748]

Correction weekly stochastic 96

[midastouch017]

I wonder what your crystal ball
is telling us?

[Sierra20]

FDA rejection or bad phase 3 results? What a drop!

[midastouch017]

Very true Fmello, i am all for ORMPs success,
although my financial estimates are somewhat
more realistic than yours!


And of course, the BIG question is what will the
mid January resuls show.

Fingers crossed.
GLTU

[Windbag1014]

Thanks Midas.

One of the reasons I am here.

Moreover if (when) ORMP can show that its unique platform can serve other
meds which are injection taken and transfer to pills, then i can safely say that
ORMP will earn the Noble Prize for this medical achievement

[midastouch017]

Metformin decreases hepatic glucose production, decreases intestinal
absorption of glucose, and improves insulin sensitivity by increasing
peripheral glucose uptake and utilization.
Insulin, at least up to date doesn't come in pill form because the digestive
system would break it down before it had a chance to work.
(Unlike Metmorfin obviously, which comes in pill)

If ORMP succeeds to prove the possibility that the insulin pill that
does not get destroyed at the liver, this will be considered a huge
success of great magnitude!
In this would be event - this would be a sort of parallel between the two pills.

Moreover if (when) ORMP can show that its unique platform can serve other
meds which are injection taken and transfer to pills, then i can safely say that
ORMP will earn the Noble Prize for this medical achievement

[Windbag1014]

When I read your comment, I think Metformin. I understand they are different animals, but do you see a parallel between Oramed and Metformin?

[Fmello]

Well, since we all own the stock, and for all our sakes, I hope I'm the one that's right. ;)

[midastouch017]

The blunt reality is that until we get the trial results, nobody knows the answer...not those Korean doctors, Dr. Peters, and everyone else.

We keep talking in circles. Of course nobody knows the trail results.
My point is but as i wrote, that even with flying colours positive results,
the pill will not capture a big market share of the insulin market, hence
your fantastic share price potential is not justified.
I wish it were.
This is my last words on this subject, you may have your last words
on this subject. Time will tell who had it right, not too long a wait.

[Fmello]

@ 53:42 in the Q&A video, Dr. Peters is asked who would be the best candidates for an oral insulin product if Oramed gets FDA approval. Her response:

"I'll go to the extremes: So if someone is on a pump...if anyone is on a therapy and doing well, I'm wildly unlikely to change it. But this gets driven by patient preference. If somebody's on an insulin pump, they need both prandial and basal insulin and they are not going to be put on this but anyone where I'm thinking of a transition if they need insulin or if they're on basal insulin already and they want to go to this, then I would certainly consider it.

Now, what I don't know in all honesty is does it mean if somebody's on 40 units of injected insulin, is it going to take away that injected insulin need or is going to be 20 units? So we will probably look at it at units per kilogram per day but I want to get a sense of how much is needed."

The blunt reality is that until we get the trial results, nobody knows the answer...not those Korean doctors, Dr. Peters, and everyone else.

[midastouch017]

Exactly my p.o.v as expressed:
see #msg-170832610
and #msg-170832717

As a matter of fact, even if positive topline results
with flying colours to be published by mid Jan, i doubt
sp will exceed $20 (for more than a few minutes until
it will simmer down to the $12-15 range level)

Mind you, i hope i am wrong, after all i still hold quite
a lot of shares.

[Amatuer17]

Read the feedback from Korea - that gives real scope of the Oramed tablet scope - it seems it will not be primary method of giving insulin but as add on method and that reduces the revenue potential

[Fmello]

If we got FDA approval, I would not be shocked if there was a news story about the big three insulin companies going into a bidding war to buy Oramed.

In 2009, Merck acquired Schering-Plough Corp in order to get their blockbuster skin cancer drug Keytruda. Merck paid 41 BILLION to buy them out. If a big company spent 41 billion to get their hands on Oramed, our stock would be worth over $1,000 per share.

[humpback]

What does anyone think of the possibility of a cash buyout for our shares?

[starkd748]

Yuppers

[midastouch017]

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

https://finance.yahoo.com/news/oramed-granted-u-combination-therapy-125500864.html

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).

"With the topline data for our first Phase 3 oral insulin trial expected soon, we continue to further fortify Oramed's leading position with respect to intellectual property assets addressing the oral delivery of therapeutic proteins currently only available via injection," stated Oramed CEO Nadav Kidron.

[dinogreeves]

There is a trick, it worked with my dog. The first few times I tried crushing the meds and place it hiding in their food, they avoid eating their own food, since they tried it the first time with the crushed meds, I guess the bitterness and they can sense the smell. This new trick worked for me, cuddle them first, then when you shove the meds in the mouth and close both jaws and blow air in their nostrils, they have no choice but to swallow it, while gasping for air.

[knick]

This dog would eat anything put near it's mouth. I'm praying for an oral insulin.

[dinogreeves]

Let's reflect on this. Bullish as phuck.

-- Topline Pivotal Phase 3 Oral Insulin Data Expected Mid-January 2023

-- Phase 2 NASH Trial Achieved Primary and Secondary Endpoints

-- Definitive Deal Signed to Commercialize Oral Insulin in South Korea

-- $160 Million in Cash and Investments (as of September 30, 2022)

NEW YORK, Dec. 21, 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 issued a Letter to Shareholders from its Chief Executive Officer, Nadav Kidron.

Dear Shareholders and wider investor community,

The year 2022 was a very strong year for Oramed. The first of our two Phase 3 oral insulin trials, ORA-D-013-1, completed enrollment with a wider scope of patients than originally planned, and we expect to announce topline results in mid-January 2023. Concurrently, our Phase 2 NASH trial delivered positive efficacy and safety data. We finished out the third quarter with $160 million in cash and investments with no debt, giving us a long runway through topline results for both of our Phase 3 oral insulin trials and filing for U.S. Food and Drug Administration (FDA) approval of ORMD-0801, potentially the world's first oral insulin capsule to reach the market.

Phase 3 Oral Insulin Trials: Top-Line Data Expected January 2023

ORA-D-013-1, the first of our two pivotal Phase 3 oral insulin trials for ORMD-0801 in the treatment of type 2 diabetes met and exceeded the number of planned participants, with 710 people enrolled. We expect to announce topline results in the next four weeks. ORA-D-013-2, our concurrent Phase 3 trial, continues to enroll the planned 450 patients, with enrollment expected to be completed in 2023.

Phase 2 NASH Trial Achieved Primary Endpoints

Our Phase 2 double-blind, randomized, placebo-controlled, multicenter clinical trial assessing the safety and efficacy of ORMD-0801 in the treatment of non-alcoholic steatohepatitis ("NASH") in 32 patients with Type 2 diabetes and NASH achieved its primary endpoint of safety and tolerability, demonstrating consistent trends across key secondary endpoints with reduction of liver fat, liver stiffness and lipids. We believe ORMD-0801 may be an ideal treatment option for the millions of people living with both diabetes and NASH. We held a Key Opinion Leader webinar in November discussing the positive data and exciting potential of Oramed's oral insulin candidate as a treatment option for this indication. The full webinar can be viewed on the Oramed website. There is currently no FDA approved treatment for NASH, which is expected to become an $84 billion market by 2029.

Definitive Deal with Medicox to Commercialize Oral Insulin in South Korea

Continuing to build global partnerships, we signed an exclusive commercial distribution agreement for South Korea with Medicox Co., Ltd. which will have the exclusive license to apply for regulatory approval and distribute ORMD-0801 for ten years in South Korea. Medicox will purchase ORMD-0801 at an agreed upon transfer price and will additionally pay Oramed up to $18 million in developmental milestones, $2 million of which has already been received by Oramed, and up to 15% royalties on gross sales in a large and growing diabetes market.

Phase 1 Oral COVID-19 Vaccine Trial Reported Positive Preliminary Data

Our subsidiary Oravax's first cohort in its Phase 1 clinical trial of our oral virus-like particle (VLP) COVID-19 vaccine for COVID-naive participants achieved its primary and secondary endpoints of safety and immunogenicity based on preliminary data. Our oral vaccine elicited a potentially protective IgG response with significant seroconversion from baseline. We believe this trial shows proof of concept for oral delivery of vaccines using Oravax's technology. Complete Phase 1 results are expected in the first quarter of 2023.

Oral GLP-1 Bioavailability Trial

ORMD-0901, our oral glucagon-like peptide-1 (GLP-1) analog capsule, is currently being evaluated under an FDA Investigational New Drug (IND) application and we expect to issue an update regarding the trial's progress in the coming weeks. GLP-1 is an incretin hormone that stimulates the secretion of insulin from the pancreas. Exenatide, a GLP-1 analog, is currently available in injectable form only. An oral GLP-1 could significantly increase compliance and become a valuable tool in the treatment of diabetes.

We are entering 2023 with real excitement for what we believe will be a monumental year for the Company. We thank you, our shareholders, for your support and we thank our partners and trial volunteers for helping advance our clinical and other efforts. We wish you all a happy and healthy new year and look forward to keeping all our shareholders updated on news and developments.

Sincerely,

[dinogreeves]

There is always a tomorrow. No one is going to leave this alone with a game changing science that World is waiting for.

[Fmello]

Yup. If the markets didn't fall into the red today, we would still be in $13 territory.

[dinogreeves]

This is going to run hard by end of the month. Good luck everyone and Happy New Years.

[Fmello]

How hard is it to get a dog to swallow a pill instead of chewing it up first?

[knick]

My dog gets 2 shots a day. It's about 150.$ per month for insulin and 40ish for needles.

[starkd748]

Here come 15s

[Fmello]

The Global Pet Diabetes Care Market size is expected to reach $2.5 billion by 2028, rising at a market growth of 8.3% CAGR during the forecast period

https://finance.yahoo.com/news/global-pet-diabetes-care-market-112200957.html

Diabetes in animals is brought on by a complete lack of relevant insulin or a poor biological reaction to it. The pancreas secretes insulin, which regulates blood glucose levels. The food that is consumed is broken down into several different substances, including glucose, which is subsequently transported by insulin to the cells and used as energy.

New York, Aug. 18, 2022 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Global Pet Diabetes Care Market Size, Share & Industry Trends Analysis Report By Animal Type, By Distribution Channel, By Solution, By Regional Outlook and Forecast, 2022 - 2028" - https://www.reportlinker.com/p06315039/?utm_source=GNW
Restricted glucose transport to the cells is caused by a lack of insulin synthesis. This causes the cells to operate improperly, and the tissue becomes energy-starved. As a result of this metabolic famine, the liver begins to metabolise extra sugar that has been accumulated in the liver, muscles, and fat cells.

Diabetes is a metabolic condition that frequently affects elderly pets, though it can also occur in younger animals. Unlike humans, some pets are genetically predisposed to acquiring diabetes; yet, obesity raises the risk of diabetes in animals. Since pet diabetes cannot be treated, growing efforts are being made to manage it as best as possible by pet owners and major players in the market for pet diabetic care equipment. The quality of life for pets with diabetes is unaffected by proper management and care. Diabetes in pets typically requires lifelong management, including a healthy exercise programme, a special diet, and, notably in dogs, daily insulin injections.

The incidence and increasing health conditions of the disease, supportive awareness campaigns launched by governments, tactics adopted by significant companies, and an increase in the number of companion animals and pet adoptions are all contributing causes. For example, Boehringer Ingelheim International overcame the pandemic hurdles by taking extensive measures and successfully maintaining its animal health business. The rising adoption of pet insurance, increasing costs for veterinary care, the return to normalcy following the pandemic, R&D initiatives by important corporations, and advancements in pet diabetic care devices are a few of the major factors fueling the expansion.

COVID-19 Impact Analysis

The COVID-19 pandemic’s advent has sharply raised public healthcare concerns that have an effect on the world economy. Numerous local and national regulatory organizations were identified to place limitations on the movement of products and individuals as the cases were reported to increase. Supply chain difficulties were found to have an impact on the total sales of the devices for treating pet diabetes with the arrival of the COVID-19 pandemic. Nevertheless, this was largely offset by the rise in demand from pet owners who wanted to stock up on important pet care items like diabetic devices for pets. Revenue in the pet diabetes care industry have decreased as a result of the COVID-19 pandemic, particularly in 2020.

Market Growth Factors

Growing Adoption Of Pets Among Population

The amount spent on pet care has dramatically grown as a result of an increase in pet adoption for companionship and safety-related reasons. The majority of pet owners are known to treat their animals with the highest care and regard them to be family members, which drives up the cost of pet care. The population of pet is constantly increasing across various nations of the world, which is creating opportunities for the pet care companies.

Increase In The Incidence Of Diabetes Among Pets

Ketoacidosis, cataracts, and kidney failure can develop in dogs with diabetes if it is not addressed. Chronic pancreatitis, nerve deterioration and ketoacidosis can all occur in diabetic cats. Early detection and treatment are so crucial. As per Vetsource, the lifetime prevalence of diabetes is currently 1 in 300 dogs and 1 in 230 cats, and these numbers are steadily rising. According to the 2016 State of Pet Health Report, over a ten-year period, the disease’s prevalence increased by over 80% in dogs and 18% in cats.

Market Restraining Factors

Low Awareness Among People About Proper Pet Diabetes Management

Although diabetes in pets is a serious disease that could be treated with medication, it could be effectively recognized early and controlled with a veterinarian’s advice, correct care, food, and exercise, assuring a long and healthy life. But, routine medication in animals has a number of undesirable side effects. Also, it has been noted that diabetic pets are more susceptible to various infections. High sugar levels may result in cataract, which may impair a pet’s ability to smell, hear, and see. Urinary tract infections are also at risk due to elevated blood sugar levels.

Animal Type Outlook

On the basis of animal type, the pet diabetes care market is segmented into Dogs and Cats. The cats segment procured a significant revenue share in the pet diabetes care market in 2021. It is because more pet owners are becoming aware of the signs of diabetes in their cats. Another element driving expansion is the rising incidence of diabetes among cats. For example, relative to dogs, cats are three times more likely to develop diabetes, as per Boehringer Ingelheim International GmbH.

Solution Outlook

Based on solution, the pet diabetes care market is divided into Treatment (Insulin Therapy, Insulin Delivery Devices and Other Treatments) and Glucose Monitoring Devices. Under treatment segment, the insulin therapy segment witnessed the largest revenue share in the pet diabetes care market in 2021. Since insulin therapy helps the body transport glucose from eaten food to other parts, it is preferred by veterinarians as that of the gold standard treatment for diabetes in pets. Given that needles could not be reused, veterinary clinics and homes have a high need for insulin delivery devices such needles, syringes, and delivery pens.

Distribution Channel Outlook

By distribution channel, the pet diabetes care market is fragmented into Veterinary Hospitals & Clinics, Retail Pharmacies and E-commerce. E-commerce segment recorded a significant revenue share in pet diabetes care market in 2021. Pet glucometers & insulin products are becoming more and more in demand as the number of families with companion animals rises. In retail vet pharmacies, a variety of brands of glucose monitors and insulin delivery pens are offered for the treatment of diabetes in companion animals. During the COVID-19 pandemic, pet diabetes products have seen significant growth in online sales.

Regional Outlook

Region-wise, the pet diabetes care market is analyzed across North America, Europe, Asia Pacific and LAMEA. North America emerged as the leading region with the maximum revenue share in the pet diabetes care market in 2021. The large presence of key businesses, the adoption of various methods developed by key corporations to expand market penetration, the rising accessibility of treatment, the increasing diagnostic rates, and the growing pet population and spending all contribute to the region’s high share. Another factor boosting the market’s growth is the rise in the number of veterinary clinics with qualified veterinarians across the globe.

The market research report covers the analysis of key stake holders of the market. Key companies profiled in the report include Boehringer Ingelheim International GmbH, Becton, Dickinson and Company, Merck & Co., Inc., Zoetis, Inc., ACON Laboratories, Inc., Allison Medical, Inc., i-SENS, Inc., Trividia Health, Inc., UltiMed, Inc., and Taidoc Technology Corporation.

[Fmello]

That 37% would then translate to 15.17 billion for Ketruda.

[Amatuer17]

Ketruda cannot be compared to Insulin - it is cancer vs diabetes
Also, MRK bought SHERING PLOUGH for $41 B - and at that time Keytruda formed 37% of total revenue

[starkd748]

I'll check

[Fmello]

I vaguely remember reading that a Nordic company has been making Oramed's pills currently. The name escapes me though.

When the skin cancer drug Keytruda got positive phase 3 results, Merck bought the company for 41 BILLION! The insulin market is larger than the skin cancer market. If one of the big three insulin companies decided to do the same and buy Oramed for 41 billion, that would translate to a stock price of over a $1,000 per share.

[Amatuer17]

Good find - I had another question -if successful - will ORMP manufacture actual insulin or convert insulin into powder form and pack in tablets?

Current insulin manufacturing is very much controlled by NOVO and LLY and few China and India mfr - so from where they will get the insulin?

On Price side - at current $12 price - the market cap is $480 m - if they prove that they can deliver in tablet form - one of the top insulin co will buy them - the BO price will be between $2.5 to $5 B - so my guesstimate is that ORMP will get 4 to 7 multiplier from current market cap

[Fmello]

It would be a gamechanger if we get confirmation from the upcoming results that Oramed's tech work. If the tech is proven to get the payload past the stomach without the strong gastric acids destroying it, then the odds go up that the same tech can safely protect a virus-based vaccine pill like covid or the flu as well.

Also, Oramed can create new revenue streams by licensing their tech to other drug companies that want to get their drugs safely past the stomach as well.

This is going to be the longest two weeks of our lives.

[Fmello]

Check out my post on #1577. Dr. Peters brings that up.

[Fmello]

This is why Novo's insulin pill failed:

https://www.reuters.com/article/us-novo-nordisk-insulin-pill-idUSKBN13B22I

"Novo’s decision to scrap the insulin pill program came as the company slashed its long-term profit growth forecast due to falling U.S. insulin prices, sending its shares into a tailspin.

Delivering a protein like insulin as a pill is hard because it risks being destroyed in the stomach. Novo scientists overcame this obstacle to a degree but still needed to deliver around 50 times more insulin in a tablet than in an injection, to ensure a sufficient dose.

As a result, the insulin pill in development would have needed to cost far more than a standard injection."

[humpback]

How about if everyone who takes injectable insulin, will also take the oral to supplement the liver insulin levels? Instead of looking at what percent of the current pie, oral insulin will be for the diabetes market, think of oral insulin as more pie added to the market. It could end up as a valuable supplement to anyone’s diabetes regimen. Possibly preventing future diabetes related health issues.

[Teekobrohey]

Vxr+ and €¥+0 are next.

[midastouch017]

I don't think it's a small market when 537 million people
worldwide have diabetes.

I did not say that, not even insinuated as much, all i think is
that even after approval, the company will not capture a
major market share, and for sure far from your farfetched
$$$ calculations of a few posts back.

Also, tack on the Nash & vaccine addressable markets
after Oramed finishes those trials as well.

First comes first. This my friend is a different issue altogether,
not related to the discussion at present which is about the diabetes
market and would be market share captured.

Disclosure: I am still a long shareholder, hoping for the best however
lowering my expectations. Good luck to all longs

[Fmello]

I don't think it's a small market when 537 million people worldwide have diabetes. The IDF predicts 783 million people will have diabetes by 2045. Also, tack on the Nash & vaccine addressable markets after Oramed finishes those trials as well.

[midastouch017]

The blunt reality is that nobody knows the answer until
the results are released.

True. But my point is that even with flying colors positive results,
ORMP pill will take a very small market share of the isulin injection
market (whenever approved, if at all to this indication)
Sorry to pour icey cold water, but i do not forsee the stock reach its
$32 level of a few months ago.
As said, all in my very humble opinion.

[Fmello]

@ 53:42 in the Q&A video, Dr. Peters is asked who would be the best candidates for an oral insulin product if Oramed gets FDA approval. Her response:

"I'll go to the extremes: So if someone is on a pump...if anyone is on a therapy and doing well, I'm wildly unlikely to change it. But this gets driven by patient preference. If somebody's on an insulin pump, they need both prandial and basal insulin and they are not going to be put on this but anyone where I'm thinking of a transition if they need insulin or if they're on basal insulin already and they want to go to this, then I would certainly consider it.

Now, what I don't know in all honesty is does it mean if somebody's on 40 units of injected insulin, is it going to take away that injected insulin need or is going to be 20 units? So we will probably look at it at units per kilogram per day but I want to get a sense of how much is needed."

Type 2 diabetes progressively worsens as natural insulin production drops. Current FDA protocols use injectables as last resort. Many other products exist to control A1C levels yet not one addresses the lack of insulin. Which is the core issue of diabetes. As Dr. Peters already stated the medical community will have to rethink the treatment of diabetes.

The blunt reality is that nobody knows the answer until the results are released.

[midastouch017]

https://www.koreabiomed.com/news/articleView.html?idxno=20133

Korean endocrinology physicians agreed that oral insulin preparations under development by Oramed Pharmaceutical would not be able to replace existing insulin injections.

They expressed the view during a press briefing where Oramed and Medicox, a local pharmaceutical company, announced the clinical status of ORMD-0801, an oral insulin candidate from Oramed Pharmaceuticals. Medicox has exclusive Korean distribution rights for ORMD-0801.

However, in contrast to Oramed's expectations, Korean doctors participating in the conference suggested that Oramed's oral insulin will be a new treatment option that can resolve some of the existing problems but will not be able to replace existing injectable insulin drugs.

"Looking at the data, I saw that ORMD-0801 is an oral insulin drug that targets the liver," Professor Kim Jae-hyun of the Department of Endocrinology at Samsung Medical Center said. "Therefore, it is important not to misinterpret Oramed's oral insulin candidate as a substitute for insulin injections for patients who need subcutaneous injections or who have very low insulin."

Professor Kim Seong-rae of Bucheon St. Mary's Hospital also agreed.

"Based on the action standard of oral insulin preparations, it is appropriate to understand the role of supplying additional necessary insulin while taking insulin injections rather than completely replacing existing insulin injections."

It seems that unlike what most of us were led to believe, oral insulin is merely
another solution to the needed, not a replacement of insulin injections.
The meaning is that the pill will not be as lucrative as expected and even if the
Phase 3 Oral Insulin Trial - ORA-D-013-1 topline results are positive, i do not
forsee a substantial price increase.

I truely hope i am wrong in my prognosis.
Thoughts, anyone?

A Happy New Year.

[Fmello]

https://www.koreabiomed.com/news/articleView.html?idxno=20133

[starkd748]

Up 100% now Technical analysis always wins

[aldo]

Repair
Stock accumulation shows great optimism before phase 3
https://stockcharts.com/h-sc/ui?s=ormp&p=D&yr=0&mn=5&dy=0&id=p78146564564

[Fmello]

Here is that Korean deal video: