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I’m seeing .37
It’s our new PARTNER! It will be in the filing! IMO. ;). Open market baby.
Come on 2 million shares
Strong. Going back up to high of day
Love seeing big days in green. Much much more to come holdin tight till I see Kevetrin in Pill Form. ;)
Almost at 1 million volume! I’m about to eat lunch.
Something is cooking. Wowza!
Hopefully partnership with validation they believe in the 600 million to 1.2 billion sales of OM upon market approval.
Leak on news... very small leak. Some family and friends of lawyers inking the deal. ;)
Power Hour! Let’s roll
The reason. It should be in $2-3 range
Hello .20!!!! Nice to see you.
MFO is done and by the looks of the OS it was much much less of them overall!!!! Hello
Damn right. Honestly it is nothing and just one indication raring to rake in 600 million to 1.2 billion in the first 3 years would take this to the moon. That is one indication.
Wow. Way less than I had projected. Interesting
Here was my advice to LE with regards to major deal hitting the wires:
1) PR it around 2PM on a Friday!
This does several things....it creates a frenzy late in a day where most are not paying attention. We could see a quick and sharp uptake for those who are short and paying attention and also those on the sidelines who are vigilant. It is a small window so you then allow the weekend to create waves and excitement and the word gets out and anticipation is extreme for the Monday opening bell! If the deal is huge which I expect it may even create a halt. Next, I would not PR anything further on Monday and come back mid week with a PR from our partner(s) and have them really hit home on the potential of OM and AGREE with and reinforce the numbers that Leo gave us on OM expectations within first few years on market...600K to 1.2 Billion easily. This will create a new wave of WHOLLY CRAP -- this stock is under a $1 and has this potential!!! by this time we could be well in the dollars though. I would then have the suitor or SEC filing show they agreed to pick up 5-10 million in open market shares as part of the deal over the next 9 months. THis again creates Buzz.....and will increase share price.
I then wait for a week and PR that BTD is still on the table and the plan is to resubmit during the interim data for both data sets per protocol.
And then release the Phase 3 plans, and all the goods that come with a powerhouse Drug with now major 3rd party backing.......This stock could easily see all time highs quickly with money in the bank which will open up IBD, Derma, and Cancer indications across the board.
So much potential here to a beat down stock price that does not resemble future growth.
GO IPIX!
No. It takes new eyes. Or it takes non dilutive funding. Everyone who is long is in. Some of us grab an extra 10-100k more shares here or there...but it’s not enough to move the bus.
They are trying to organically make the public aware of the potential ipix sees in OM alone. But at this time, the public is at a show me not tell me stance. IMO.
I think we have to be close. FDA meeting minute announcement is a key milestone and if both fda and EMA are ready to roll - I’d think someone will be ready to fund phase 3 and reap the returns.
I mean.....I would not go that far....lol. I just think the FDA minutes are important for partners as is EMA meeting info. I also think there is a buyer with no MOFO.
Great to see! A squeeze could happen if we ink a 300 million deal imo. If the booogy man stories are true. ;)
Go ipix!!!
I don’t care. Down or up...I’m not selling. But the minutes are now available. That is all that matters.
Innovation Pharmaceuticals Receives FDA End-of-Phase 2 Meeting Minutes
Guidance to Inform Brilacidin Oral Rinse Phase 3 Program for Prevention of Severe Oral Mucositis
BEVERLY, MA – May 1, 2019 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage pharmaceutical company, announced today it has received Food and Drug Administration (FDA) End-of-Phase 2 (EoP2) meeting minutes, helping to guide the Company’s planned Phase 3 program for Brilacidin oral rinse to decrease the incidence of Severe Oral Mucositis (SOM) (WHO Grade ≥3) in Head and Neck Cancer (HNC) patients receiving chemoradiation. Brilacidin oral rinse is being developed under FDA Fast Track designation for Oral Mucositis (OM).
During the EoP2 meeting convened in December 2018, the Company and FDA agreed to an acceptable Brilacidin Phase 3 development pathway. The guidance from the FDA now also helps to frame ongoing discussions with the European Medicines Agency (EMA) as part of the Scientific Advice process. The purpose of both of these interactions is to ensure that proposed plans meet regulatory requirements for New Drug Application (NDA)/Marketing Authorization Application (MAA) filings and, ultimately, to obtain approval of Brilacidin for SOM in HNC in both the United States and Europe.
“Productive regulatory meetings for our Brilacidin SOM program with U.S. and European agencies are significant Company milestones,” commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “Brilacidin oral rinse, to decrease the incidence of SOM, represents a potential future regimen for millions of head and neck cancer patients where no approved drug is available today. Furthermore, our hope is that Brilacidin will eventually emerge as a treatment for other indications where SOM also is a frequent side-effect of cancer therapies.”
“It is time that the current standard of care for SOM takes a leap forward and a new market emerges,” added Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “I am reminded of drugs for not only rare diseases that were overlooked by the market during development and then went on to become ‘company makers,’ but also a drug such as Tagamet. Eventually, it became the first blockbuster drug ever by treating the common problem of acid reflux, a disease that was casually written off for decades as not having an effective treatment beyond antacids. Treatment-related SOM in cancer patients is a real problem worldwide, affecting millions of patients, with physical and financial ramifications that genuinely must be addressed beyond today’s magic mouthwashes. And, we are currently the only company with an oral drug candidate being advanced into late-stage trials, positioned to fill this unmet need. I greatly look forward to initiating our planned Phase 3 program, adding further credibility and value to our Brilacidin Franchise.”
About Brilacidin Phase 2 OM Trial/Comparison with Other OM Drugs in Development
The Company’s Brilacidin oral rinse demonstrated a strong therapeutic benefit in patients receiving the aggressive chemotherapy regimen (cisplatin administered 80-100 mg/m2, every 21 days), which currently is in common use. In this patient population, incidence of Severe OM (WHO Grade ≥ 3) was reduced to 25.0 percent in the modified Intent-to-Treat (mITT) population, versus 71.4 percent of placebo patients. In the Per Protocol (PP) patient group, incidence of Severe OM dropped to 14.3 percent for patients receiving Brilacidin, compared to 72.7 percent among those receiving placebo.
The completed Phase 2 study (see NCT02324335) met its primary endpoint, showing a reduction of Severe OM incidence versus placebo, as well as beneficial treatment effects in reducing the duration of Severe OM and in delaying the onset of Severe OM. Furthermore, Brilacidin showed a favorable safety profile and was well-tolerated.
Linked below is information, published in a blog on the Company’s website, elaborating on how Brilacidin is positioned compared to other investigational Oral Mucositis drugs in clinical development.
http://www.ipharminc.com/new-blog/2018/9/24/brilacidin-for-oral-mucositis-at-a-glance-comparative-data-presentation-with-other-investigational-om-drugs
About Brilacidin and Severe Oral Mucositis
There currently are no FDA-approved drugs for the prevention of Severe OM (SOM) (WHO Grade ≥ 3) in HNC patients receiving chemoradiation. The additional expenses incurred by patients suffering from SOM are estimated to be as high as $18,000 to $25,000 per case in the U.S. when hospitalization is required. These factors contribute to SOM qualifying as an area of significant unmet medical need. According to published statistics, the number of new annual HNC cases in the U.S. is estimated to be 65,000, and worldwide, ~750,000 cases. Between 60 and 70 percent of these HNC patients typically will develop Severe OM, with the overall incidence of HNC patients developing some grade of OM (WHO Grades 1 to 4) approaching 100 percent. Because it cannot be predicted which patients will develop SOM, a preventative treatment, such as Brilacidin oral rinse, would begin in all patients as soon as starting chemoradiation and continue until its completion (typically a seven-week course). Given Brilacidin is administered as a convenient oral rinse, with plans to package it in an easily transportable sachet form, the Company believes it would be attractive both to doctors and patients—likely translating to widespread and rapid market adoption should Brilacidin oral rinse gain regulatory approval.
Alerts
Sign-up for Innovation Pharmaceuticals email alerts is available at:
http://www.ipharminc.com/email-alerts/
Agree Karin. I also believe that the super high daily short % is because of dilution by MFO as well. I have traded several sub stocks for many years and that % is always high during the exercise phase. ;)
Here is one other observation. I believe Leo would reverse split if he knew he had no chance at a deal. We need money and need it soon because BOM is in a race so imo I would reverse split ASAP to raise money. We have a real good chance to make it to market so in the end a RS would not be a killer imo. But the fact he has not....gives me a feeling we are and have been close to finalizing a deal. IMO.
I’ve got another 10K in cash ready for that day. Bring it!
I believe there will be a collaboration between a few smaller bios and will lead to bigger money in the end for ipix. It aligns with Leo’s stubbornness and smarts to get what we as shareholders deserve. I am not sure I am buying that BP only want cancer cures...this OM is a blue sky indication in the cancer realm...and preventative to boot. I could buy.......that BP and their arrogant attitudes are low balling or have low balled Leo due to current share price strength.....and therefore Leo will find smaller bios who align in strategy to get bought out in the future by BP for a much much larger sum!
Good luck. To us shareholders.
Well my point was......everyone wrote him off as a dead man walking and he came back! Ipix will be the same and in multiples. IMO.
IBD/OM/Derma/Kevetrin will equal the grand slam of golf.
Let’s wake up to a SIGNIFICANT deal and roadmap to phase 3 of BOM.
I’d say ipix is leaps and bounds less risky thanTiger winning the masters. When was his last masters win? 2005? Or 2009? That’s a 10-15 year drought.
Ipix is at 7 years for me. 3 to go and by then I expect bom to be raking in 1 billion dollars a year.
I still believe we see a deal in April. Time to move fast on OM and start that phase 3. No time to waste and all parties understand what’s at stake. IMO.
A signed deal can happen at any point. Kevetrin could ink one today. It’s all dependent on what IPIX mgmt are seeking. If too low they continue onward until a partner offers what they are looking for. IMO.
Look at all the pre clinical deals, the phase 1 and 2. I suspect this deal will be complex and have multiple suitors. The stage is set. The table is set. Whatever you want to call it....if fda and EMA. Are aligned - this is phase 3 ready and full steam ahead. Who wants part of 600 million minimum?
You got it. Deal halts trading. Opens in mid $2’s. With an agreed upon 600 million to 1.2 Billion sales of B-OM....that should fetch a considerate upfront to roll through phase 3. If IBD is involved.....who knows what kind of upfront! Could be game changing.
Ways to go. Goal is to start trial early summer. IMO.
They sell 50 million in merchandise. Unreal. Go ipix.
Pete. Ipix estimates that BOM will bring in 600Million to 1.2 billion within the first 3 years on market. This number is the ANCHOR of all discussions regarding partnership.
We were told this information imo because that is one of the most important numbers in the formula to partner. The competition factor is much smaller than most drugs for other indications because for OM...there really is nothing and the other few in phase 3 are IV.
So the question we ask...we are entering phase 3. Percentage of failure? Trial Cost? Time? Market penetration? increase in disease? If I’m a partner, how much am I paying ipix to gain a min of 600 million a year for the next 12-14 years plus a possible additional 3-5 years exclusivity? Masters time.
Let’s see that After Hour deal PR!
Great artivle
Race Heats Up for a Blockbuster Oral Mucositis Drug; Look Now Before Wall Street Catches On
By Benjamin Roussey - April 10, 2019
Oral mucositis, or OM, is a very real problem for cancer patients, with essentially every head-and-neck cancer (HNC) patient receiving chemoradiation developing lesions in the mouth that can become so severe that the person can’t eat or drink and cancer therapy has to be suspended. Trying to be proactive, hospitals concoct their own “magic mouthwashes” to help alleviate the condition, but the proof is in the pudding that they just aren’t very effective.
That means hundreds of thousands of patients worldwide must deal with severe OM annually. With no FDA-approved drugs for the prevention of severe OM in HNC patients getting chemoradiation, it also means that there is a tremendous market opportunity available to help these people.
South Korea’s Enzychem Lifesciences estimates that a drug for chemo-radiotherapy induced OM would generate sales of $2.6 billion globally each year. Based on preliminary estimates of Innovation Pharmaceuticals (OTCQB: IPIX), the total OM market opportunity in HNC annually in the U.S. and Europe would be approximately $600 million to $1.2 billion.
If and when a drug is approved, a huge market is going to erupt. Private and government insurances can’t afford not to spearhead a movement to get an effective drug into patients considering each case of severe OM comes at an in-patient cost in the range of $18,000-$25,000. That goes without mentioning the better quality of life for patients.
A drug that is prophylactic would need to be given to all approximately 120,000 HNC patients in the U.S. and Europe at the outset of chemoradiation and continue throughout the treatment course. Now extrapolate that to the ~750,000 HNC patients worldwide. Further, factor in off-label use owing to the fact that up to 60% of patients receiving chemotherapy for their cancer, regardless of origin, develop OM.
Taking a look at the price of palifermin (trade name Kepivance) provides some guidance on potential pricing. Kepivance is the only drug available to treat OM, but it is exclusively indicated for hematopoietic stem cell transplantations, not solid tumors.
It is fair to estimate a new treatment could fetch between $5,000-$10,000 per course, lending credence to the estimates of both Enzychem Lifesciences and Innovation Pharma for a new blockbuster drug opportunity.
Despite the robust market potential, Wall Street doesn’t give a great deal of value to OM drugs in development, but that is something that could soon change.
Perhaps analyst’s bias is because no one has been successful yet at developing a drug. Maybe it is due to the fact that some “drugs” that made it to market weren’t actually drugs at all and ended up being commercial failures. For the most part, therapeutics that made it through the FDA’s 510(k) pathway – which qualifies them as a “medical device” and not a “drug” so they aren’t subject to the stringent qualifications to reach the market – are little more than magic mouthwashes. It makes sense that they don’t garner hospital adoption considering that they compete with the hospitals’ own magic mouthwash.
And, again, the fact is that they just don’t work very well as evidenced by statistics showing that some 60%-70% of HNC patients develop severe OM.
To that point, there is a huge difference between existing OM therapies and what companies like Innovation Pharmaceuticals (OTCQB: IPIX) and privately-held Galera Therapeutics are working on, respectively. These companies are each developing bona fide drugs to reduce the incidence, severity and duration of severe OM, but doing so with very different approaches.
Both companies are developing their experimental drugs under FDA “Fast Track” designations.
For its anti-OM strategy, Innovation Pharma is developing Brilacidin oral rinse, a “swish and spit” formulation of its potent and versatile lead drug candidate from a novel group of drugs called “defensin mimetics.” Innovation last year completed a Phase 2 trial of Brilacidin oral rinse that hit its primary endpoint in reducing the incidence of severe OM in HNC patients receiving chemoradiation, as well as other important readouts regarding shortening duration of severe OM and delaying the onset in cases where it did occur.
The data further showed that Brilacidin was particularly effective at reducing the onset of severe OM in patients receiving a more aggressive chemotherapy regimen (a higher concentration of cisplatin administered every three weeks). This is important to note because it is this regimen that is the standard of care today for cisplatin therapy.
In the per protocol population, the relative incidence of severe OM was reduced to just 14.3% compared to 72.7% in the placebo group.
Following an end-of-phase 2 meeting with the FDA, Innovation has the agency’s blessing to move forward with a pivotal phase 3 trial. This study will be of international scale, for which management is having a meeting this week with the European Medicines Agency (EMA) to ensure all protocols for the study are structured to meet European guidelines with the intent seek EMA drug approval in the future.
On Tuesday, Innovation said that it has made yield and purity enhancements in the manufacturing of Brilacidin for the bulk production of Phase 3 drug supply. While it might seem like a yawner to anyone but a scientist, the company is optimizing the chemical process as it looks up the road towards commercialization, should its trials be successful.
First up in those trials will be the phase 3 in OM, along with a new phase 2 trial to build upon a successfully completed study using Brilacidin for Inflammatory Bowel Disease.
For its part, Galera’s GC4419 is a first-in-class, small molecule enzyme mimetic that converts superoxide to hydrogen peroxide and molecular oxygen. GC4419 is administered through a 60-minute IV infusion.
After success in early and mid-stage trials, Galera in September began a phase 3 trial of GC4419 in patients with locally advanced, non-metastatic HNC receiving chemoradiotherapy. The trial’s primary outcome measure is cumulative incidence of severe OM.
Likely owing to the experience of Galera chief executive Dr. Mel Sorenson, the company has been extremely successful at raising capital to fund its research. Dr. Sorensen has raised over $300 million in multiple private financing rounds during his career and has led licensing deals for several preclinical and clinical-stage compounds, which has caught the eye of a bevy of investors. The company recently raised $150 million, broken down into a $70 million equity raise and an $80 million royalty financing payable from future sales.
Take note that investors are looking ahead to sales; those paying attention to the industry opportunity expect good things.
The completed Galera studies delivered compelling data about the efficacy of GC4419, including indicating that the drug decreases frequency of severe OM, delays the onset and shortens the duration when it occurs, much like that of IPIX.
In fact, Innovation Pharma has not been shy about putting data from each of their phase 2 trials side-by-side for comparison. This chart includes not only endpoint efficacy data for Brilacidin and GC4419, it also shows SGX942 (IV infusion) from Soligenix (NASDAQ: SNGX), Clonidine Lauriad (mucobuccal tablet) from Onxeo, now Monopar Therapeutics, and Kepivance (palifermin), marketed by Biovitrium.
While a smaller sample size, the data shows that Brilacidin was comparable across the study and outstripped the others in patients treated with high cisplatin regimens.
There is a feeling that something transformational is going to come to the OM space in the coming years, as Brilacidin, GC4419 and SGX942 move through their phase 3 studies. Anything can happen in the world of biotech, but it seems almost certain that one of these drugs will be the first ever approved by the FDA, quite possibly more than one. The intravenous drugs by Galera and Soligenix have a head start with regards to trials, but it is arguable that Innovation Pharma has the lead when it comes to ease of administration because patients prefer an oral therapy over IV and it can be administered in any setting, which keeps costs down and makes it appetizing to payers.
MOMO and team will swoop in and you just watch....the actual partnership we’ve been waiting for-for years will happen as they take huge positions. The flippers will make millions here. I have no problem with that, but I’d like to grab some more myself first. :)
Welcome and I hope your name is accurate and you are now here!
Big volume!!! Let’s close green and strong!!
Can someone sticky that article please.
Great Article-Awareness!
Did you read the actual estimates? That’s not smoke Dunn. So if I’m Bio or BP. I’m willing to throw down 20 million today to put myself in front of line and follow up with 100s of millions after phase 3 to gain a billion dollar drug. No brainer. IMO
However....it’s tricky when we are talking about addding IBD. That is just so valuable and we only dosed several patients...so I am eager to see what that comes out to.
I’m just happy to see information of how much they are expecting to charge for B-OM. And they are giving us US and Europe estimates.
Remember they have already met with the US government to discuss costs and savings.
This data is shared and agreed to by possible partners....meaning that will be our value soon enough. Just need that validation: that will come on deal day when the CEO of our partnering company PRs to his shareholders their expectations of B. Can’t wait
Agree with you. Getting on a major exchange will be key in all of this.
Aim small miss small I guess for you :)
Yup. My 300mm which is the AS is my assumption we dilute to there over the next year or two. That’s if we don’t partner with big upfront which I believe we will very very very soon. We were around 180mm last Q with 909k series B
I would predict a buyback of shares before we hit my 300 comment.
But I am just gauging how undervalued we are if in 3 years we rake in 600-1.2. This is just OM —-
IBD is multiples in value. The market will reach mid 40 billion in the upcoming years.
Kevetrin is just mind blowing if we go there.
Cheers to many many of billions in Revenue for Ipix drugs. IMO.