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There was another quote somewhere, that Pfizer’s combo pre-clinical data with Kevetrin was the only combo to date where they saw the type of shrinkage....ever!!!!
Last post; where is the quote? About cancer drugs will pull in 100 billion or something in 2020 and the top 5 or 10 will bring in 90 plus. Kevetrin could end up as #1 of that group. IMO.
Half of all cancers - combo therapies. Kevetrin. What if? Honestly! What if it works? How much?
Honestly! All you naysayers, Bunhun, SS dud rdunn - if Kevetrin does modulate p53 mutant and wild type....and somehow is formulated to Oral. Come on:::::: that’s $$$$$. And more than anything we will have seen for a cancer drug. EVER! Mark it
Here is exact quote from Feb 10 PR
So the scientists at DF involved with the phase 1 URGED IPIX TO SELECT THEM FOR FUTURE TRIALS. That’s pretty cool SS.
“For Cellceutix, there is a lot of activity going on in Texas. Elsewhere, when we mentioned the bioavailability achieved in oral Kevetrin to scientists at our previous Phase 1 clinical site, they commented that it could represent a significant improvement to lengthy or frequent intravenous infusions and urged us to select them as a site for future Kevetrin trials. That is very encouraging, as they are some of the most respected and experienced investigators in the world,” commented Leo Ehrlich, Chief Executive Officer at Cellceutix. “The Company is taking a major step not only toward developing a potent new cancer drug, but one that may become the first ever shown to safely modulate p53, with the added benefit of oral delivery.”
Great Kevetrin PR; safety studies are probably close to being released for Oral K. They said they should complete end of 2017. Maybe we get data soon!
Cellceutix Provides Update on Developing p53 Drug Candidate Kevetrin as an Oral Anti-Cancer Agent
Kevetrin
BEVERLY, Mass., March 03, 2017 (GLOBE NEWSWIRE) -- Cellceutix Corporation, (OTCQB:CTIX) (“the Company”), a clinical stage biopharmaceutical company developing innovative therapies with dermatology, oncology, anti-inflammatory, and antibiotic applications, is pleased to update shareholders on continuing efforts to develop the oral dosing of Kevetrin.
Based on positive results from Cellceutix’s Phase 1 trial of Kevetrin in solid tumors conducted at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center, the Company is moving forward with a Phase 2 trial of intravenously-administered Kevetrin in patients with late-stage, platinum-resistant ovarian cancer. Cellceutix has decided to pursue an oral formulation for Kevetrin to improve patient convenience and potentially increase therapeutic efficacy given the drug’s short half-life and other pharmacokinetics, as discussed below.
As background, pre-clinical work determined the bioavailability of Kevetrin was 79 percent when given orally in Sprague-Dawley rats. To further establish the efficacy of oral Kevetrin, in vivo mouse studies were carried out in an ascites ovarian tumor model using OVCAR-3 and OV-90 tumor models, both of which possess different mutant p53 genes. Importantly, these pre-clinical results showed that the overall efficacy of Kevetrin was similar across both oral and intraperitoneal routes of drug administration.
Cellceutix has initiated a series of GLP (Good Laboratory Practice) studies to assess the safety of Kevetrin given orally. Considering that Kevetrin is a non-cytotoxic drug, our intent, with FDA permission, is to next proceed with a Phase 1 clinical trial in healthy volunteers using the oral route. These studies are being conducted by approved vendors and include: photosafety testing, pharmacokinetics, in vivo metabolism, metabolic stability, protein binding, and genetic and physiological toxicology reports.
Preliminary data analyses in a pharmacokinetic study in rats revealed a half-life of approximately 1 hour and a clearance of 78ml/min/kg for both oral and intravenous (IV) dosing. Results of an initial photosafety study demonstrated a molar extinction coefficient value of less than 5 L/mol*cm over a range of wavelengths above 290 nm, well below the 1000 L/mol*cm limit stated in ICH guidelines—indicating Kevetrin has no phototoxicity. A preliminary toxicity study showed that at doses up to 500 mg/kg given orally daily for 7 days, Kevetrin was well-tolerated by the rats as indicated by an 11 percent increase in body weight and no abnormal clinical observations. Further, this dose was greater than the doses used in the preclinical efficacy study. Remaining safety studies will be completed in the second half of this year.
In related news: Last week, Cellceutix research partners in Italy shared results with the Company from their ongoing preclinical work evaluating Kevetrin in Acute Myeloid Leukemia (AML), Pancreatic Cancer and human Gliobastoma Multiforme (hGBM). The data will be presented (by them) at scientific conferences, and is consistent with, and further informs, our knowledge of Kevetrin. Also, efficacy data from the 2nd cohort in the Brilacidin-Ulcerative Colitis proof-of-concept study is in the last stage of being compiled by the CRO and, following a final review, will be released.
It sure is. It’s at the end of a PR or article where Leo states...at a previous prestigious sponsor of a phase 1 trial came back and asked to be considered a host for future trials if an oral formulation could be achieved. I will find it
Where is the PR that states Leo telling the public that DF is asking IPIX to please consider them as a trial host if IPIX can reformulate K to Oral? Anyone?
——————————-
“I just did a screen on common US stock (no ADRs):
Industry: Biotech and Pharma
Revenue TTM: 100M to 2000M
Revenue Growth TMM over TTM: < 200 %, to cut off cos having a insane revenue jump TTM over TTM
Surprise: Average price to sales ratio still about 9 and average revenue growth 23 %.
Apply that to future IPIX with 1 B$ revenue from one drug with growth potential in excess of 23 % year over year, which IPIX should be able to achieve easily with the rest of its pipeline. You get potential (and conservative) market cap 9 billion. Let's assume 200 million share (now about 140 million).
That gives for potential (and conservative) share price 9000/200 = 45 bucks.
Version 2: Assume 15 % royalty income. That is 150 million. But this income goes directly to earnings (no cost of goods etc). Can't use price to sales ratio because it does not apply here. Must use P/E for 75 cent per share earnings. Screen gave average P/E 50.
That gives future IPIX (conservative) share price of 37.5 USD.”
What’s so funny. PlentyParanoid did a share price breakdown for a single billion dollar drug with a maximum OS of 200 million.
He did a straight 1 billion fully owned by the company - no partner = 47 plus per share
Then did a license deal with royalties and it came out to high 30’s per share.
Facts
So I’m not funny or lying here
That would warrant TOP DOG in Oral psoriasis. Meaning ATLEAST 2 billion a year once on market
Meaning a 60 dollar plus share price
Prediction: we see the data in Feb
The data is going to blow your mind. PASI 75 at 43% is my dart.
All day every day. Why? If they were retail you would think you would see them go both ways or quiet down at some points.
"Many of the largest, most cash-rich companies in the industry have not even begun to participate in M&A, and when they do, prices and deal volumes could step up significantly," Leerink Partners analyst Geoffrey Porges wrote Monday in a note to investors. “
Ipix
Drug Firms Bet Billions on Biotech -- WSJ
Source: Dow Jones News
By Jonathan D. Rockoff
This article is being republished as part of our daily reproduction of WSJ.com articles that also appeared in the U.S. print edition of The Wall Street Journal (January 23, 2018).
Big drugmakers, searching for new sources of revenue, are paying hefty premiums for biotechnology businesses, with two multibillion-dollar acquisitions announced Monday among the latest such deals.
Sanofi SA agreed to pay $11.6 billion in cash, a 63% premium, to buy hemophilia-drug company Bioverativ Inc., confirming a Wall Street Journal report Sunday.
And Celgene's cash deal to buy Juno Therapeutics Inc. values shares in the biotech company at $9 billion, 87% more than their worth before the Journal reported on the deal talks last week.
So far this year, the median premium paid in health-care deals worth more than $1 billion is 89%, almost double the median of 45% since 2010, according to Dealogic.
Both Sanofi and Celgene have been looking to add products to cope with lower-price competition looming for their top-selling drugs.
As big drugmakers look to deal-making, rather than their own laboratories, to plug gaps in their product lineups, they are increasingly willing to pay up for the scarce roster of companies with promising products.
And analysts say premiums may only get bigger as other large drugmakers, aided by the new tax law in the U.S., consider acquisitions to bolster their lineups.
"Many of the largest, most cash-rich companies in the industry have not even begun to participate in M&A, and when they do, prices and deal volumes could step up significantly," Leerink Partners analyst Geoffrey Porges wrote Monday in a note to investors.
Paris-based Sanofi has already missed out on two high-valuation deals. It lost the bidding for Medivation to Pfizer Inc., which paid $14 billion for the cancer biotech company in 2016.
Then last year, Johnson & Johnson outbid Sanofi to buy rare-disease drugmaker Actelion for $30 billion.
Bioverativ, of Waltham, Mass., sells two top-selling treatments for the rare blood disorder hemophilia. The company was spun out of big biotech Biogen Inc. last year after Biogen couldn't find any companies willing to buy it for about $3 billion, according to a person familiar with the matter.
Sanofi turned to Bioverativ as low-price competition drew closer for the French company's top-selling product, Lantus insulin. Lantus revenue has been dropping but still accounted for 13% of Sanofi's sales during the first nine months of 2017.
Bioverativ's hemophilia drugs will fit in Sanofi's rare-disease business and complement the company's collaboration with biotech Alnylam Pharmaceuticals Inc. in developing a new kind of hemophilia therapy using an emerging technology called RNA interference.
"With Bioverativ, we welcome [a] leader in the growing hemophilia market and that will create a platform for expansion in other rare blood disorders," Sanofi CEO Olivier Brandicourt said in a conference call.
Sanofi said adding Bioverativ will be "immediately accretive" to its earnings in fiscal year 2018. Yet traditional hemophilia drugs from Bioverativ and other drug companies could see sales drop over the long term if gene therapies now in development work out and take over the market.
As for Celgene, the Summit, N.J., company is a major seller of blood-cancer drugs. But competitors have been challenging the patents protecting its top-selling product, multiple myeloma treatment Revlimid, in their efforts to sell generic versions.
In advance of Revlimid's patent expiration, Celgene has been entering partnerships with biotech companies working on promising new drugs for cancer and other diseases. While waiting on the collaborations to pan out, Celgene has added some products through acquisitions.
Just this month Celgene agreed to pay $1.1 billion upfront for Impact Biomedicines, a privately held cancer biotech company, and committed to spending billions more dollars if Impact's blood-disease drug is approved for sale and reaches other milestones.
By acquiring Juno, Celgene will gain access to a new kind of blood-cancer treatment, known as CAR-T, which modifies a patient's own immune cells to turn them into potent cancer-fighting agents.
The Juno deal "is an important step in executing our strategy to sustain industry-leading growth by focusing on disruptive, innovative medicines and immediately establishes Celgene as global leader in the rapidly emerging field of cellular immunotherapy," Celgene CEO Mark Alles said in a conference call with analysts and investors.
Celgene said the Juno acquisition won't become "incrementally additive to net product sales" until 2020. It also predicts that Juno's most-advanced drug, JCAR017, will peak at $3 billion in yearly world-wide sales.
But some industry officials and advisers question how lucrative the drugs will be unless they can be used beyond blood cancers and don't have to be tailored to each individual patient.
Celgene's valuation of Juno was influenced by Gilead Sciences Inc.'s $11 billion acquisition of Kite Pharma, which also has a CAR-T treatment. Gilead said it paid a 50% premium to the 30-day volume-weighted average of Kite's stock price.
Celgene executives said on a conference call with investors that the company will continue looking for acquisitions.
--Cara Lombardo contributed to this article.
Write to Jonathan D. Rockoff at Jonathan.Rockoff@wsj.com
An otcbb stock price is not market value. I know for a fact. That BP knows and have discussed with IPIX what possible values their drugs are worth and it’s in multiple of 10xs. Currently.
Just because the market in penny land are morons does not mean it’s true value.
I can spew dozens of stocks valued way beyond what they are worth because they have crowds of momo and other pump groups. Does that mean those stocks that have zero value are worth hundreds of millions?
Absolutely not. That is the beautiful thing about biotech and science. When you find a company that truly has the science and the pipeline. The true value will be unlocked with good management. And I promise you, we have the best management.
People are nuts. Let’s give away a dollar in return for a penny. Smart
What are we thinking comes next?
A. Prurisol phase 2b topline data?
B. Kevetrin Oral formulation Update?
C. Brilacidin for IBD update on next step?
D. Brilacidin B-OM final study report? More data?
E. Brilacidin OM Breakthrough Designation submission to the FDA?
F. Deal or License?
G. Kevetrin - addition data for the phase 2 Ovarian Cancer? RECIST data
Any guessers?
I ate some pistachios today while reading this board. Cracking those things are so much more fun. I’d expect a lot of days like this until BOOM - we get smacked in the face with a legendary deal.
Bio is hot. IPIX will be hotter
Soon longs.
I just listened to the BIotech presentation. I’d love to be as balanced as Art. He seems so calm and collective. Well done! I would be beating drums, screaming and dancing at that podium.
Quick note on Kevetrin. He mentioned that it takes a 180minutes to infuse Kevetrin Is that normal infusion rates for cancer patients? I know the only way for K to really take off is Oral, but was curious if anyone knew the rates of other treatments.
I’m assuming these patients have to be hooked up for 3 hours and 3 times a week. My heart goes out to them.
I would hook myself up for 6 hours every day if it meant a possible cure of cancer...don’t get me wrong.
Anyway, ANCHOR was the key note thru that presentation. And IPIX feel Brilacidin is 100% anchored and they are 100% ready to partner. ;)
Do me a favor. Take the time and reread KarinCAs interview with Dr B. It is unreal how steady and focused IPIX is.
Great post from PP on valuation for B-OM alone:
—————————————-
“I just did a screen on common US stock (no ADRs):
Industry: Biotech and Pharma
Revenue TTM: 100M to 2000M
Revenue Growth TMM over TTM: < 200 %, to cut off cos having a insane revenue jump TTM over TTM
Surprise: Average price to sales ratio still about 9 and average revenue growth 23 %.
Apply that to future IPIX with 1 B$ revenue from one drug with growth potential in excess of 23 % year over year, which IPIX should be able to achieve easily with the rest of its pipeline. You get potential (and conservative) market cap 9 billion. Let's assume 200 million share (now about 140 million).
That gives for potential (and conservative) share price 9000/200 = 45 bucks.
Version 2: Assume 15 % royalty income. That is 150 million. But this income goes directly to earnings (no cost of goods etc). Can't use price to sales ratio because it does not apply here. Must use P/E for 75 cent per share earnings. Screen gave average P/E 50.
That gives future IPIX (conservative) share price of 37.5 USD.”
—————————————-
This puppy will go much much higher imo.
Let’s see what P phase 2b shows. That could potentially change everyone’s opinion. Imo.
That is not the attitude to have. IMO. Great bio investments take decades, you have made it thru the toughest parts, pre-clinical thru phase 2bs. We now have a 60%+ chance to approval. Those odds are phenomenal.
This is when smart money will start to enter. Big money will be entering over the next six months. You should be more excited than ever. Everyone should. Imo
Actually DF wants to be the trial site when Oral is available. It’s publicly stated.
I like more on the backend right now. Again, just a deal is validation. We need real coverage. Real analysts will peg this MC much much closer than it is now. IMO.
Too much. IMO. Way too much.
I love thinking about that, but a phase 3 ready drug would need to be exceptional....like...99.9% prevention rates to garner that.
Valvide was 1 million upfront
100+ in milestones
Double digit royalties that will increase as sales do.
I know we trump that drug, and also are one of the only shows in town for prevention. So I believe ours would be higher.
I’d like to see something like 10 - 15 million upfront 10 million in open market share purchase paid for phase 3 and milestones fore BTD and specific phase 3 read outs. With double digit royalties that can also increase as sales do.
However, I think we have a single suitor for all of B. I think it’s Pfizer - just my hunch.
It will be interesting to see how many shares IPIX taps from the Aruda filing to the next Q. If no deal by then, I think that will tell us something.
IMO. They have their suitor in mind. But letting the market know that others are becoming more interested which in turn hopefully sparks more interest at higher prices or moves the process along quicker.
If it’s a B deal which appears so, and for all B, it will be a suitor close to Dr B IMO.
If it’s just B-OM, they will most likely have multiple licenses imo and use that indication to raise the MC in. Big way and start the domino fall which will garner more money and puts IPIX in the driver seat moving forward. IMO.
I personally would like to see this done prior to P results.
Conferences. Plural. So obviously they walked across the street to the JP as Leo advised. Invitations to some very high level meetings.
The more the merrier for us...it will make some compete and put the pedal to the medal. Stay focused and professional and entertain as many offers as possible. IMO.
Again...always Aspire to you, however they only sold 42K in last 2 months. That’s your opinion it’s Aspire.
Imagine if we ink a deal. Big deal for all of B and the P data is more robust than we all thought. BOOOOOM TIME
Leo would not suggest we are close to deals if it was not very imminent imo. We’ve been thru too much to do so. I bet IMO we got new offers last week. Now they go back to Beverly and discuss who is our best fit.
I think we see deal prior to Prurisol data. Just a guess
Daily IV for 60 minutes? For 7 weeks and then you go in for CR after? Ighhhh. That is rough.
Here’s my thought. No word or updates on B-UC/UP or other IBD recently. Very tight on tapping Aspire since Nov - only 42K shares in 2 months, while our lifeline has been tapping 100’s of thousands per month if not millions at this share price.
I think Brilacidin is up for a partner and I think the entire platform is on the table with mega bucks at milestones.
Cabel. Thanks. Leo is a great leader and very intelligent. People often forget the reason he and Dr M are in this. Thanks again for the open communication.
Great weekend re-read: http://c.ymcdn.com/sites/www.bioflorida.com/resource/resmgr/imported/ShareVault%20whitepaper%20-%20Getting%20Ready%20for%20BioPharma%20Partnering%20v2.pdf
Remember Leo confirmed they have had a great virtual room with cable!
Our time is near friends. IMO.
Whoa........Aspire is selling!!!!!! Omg....... actually only 42K in 2 months. Bullshit
Found it! Here you go:
From the 8-K: 9.9.13: "The acquisition includes the PolyMedix pipeline of nine compounds as well as the substantial equipment assets at PolyMedix’s 25,000-square-foot headquarters and laboratory."
https://www.bamsec.com/filing/135525013000032?cik=1355250
Less than two years ago, PolyMedix had 28 employees, a market capitalization of $227.4 million and was rated as “outperform” by a well-known investment banking firm.
Otherwise CTIX IPIX has 8 Compounds - so 8 + 9 = 17
Kevetrin Cancer
KM 133 Psoriasis
KM 391 Autism
KM 277 Arthritis
KM 278 Arthritis/Asthma
KM 362 MS/ALS/Parkinsons
KM-3174 Cancer
KM-732 Hypertensive emergency
Here are RIGHTS associated with:
Payments Related to Assignment of Compounds
The Company has been assigned all rights, title, and interest to the following eight pharmaceutical compounds: Kevetrin, KM 277, KM 278, KM 362, KM 3174, KM 732, and KM-391. The Company agreed to pay the assignors 5% of net sales of the compounds in countries where composition of matter patents have been issued and 3% of net sales in other countries. Kevetrin, KM 277, KM 278 and KM 362 were acquired by the Company from Dr. Krishna Menon, a Director, the Company’s President of Research and Chief Scientific Officer, and a principal shareholder. With regard only to Kevetrin, the allocation of the 5% of net sales would be as follows: 2% to Dr. Menon, 2% to an unaffiliated third party, and 1% to Leo Ehrlich, our CEO. With respect to KM 732, the Company has agreed to pay an individual a fixed payment if the compound is approved for sale in the U.S. The Company owns all rights to Prurisol.
https://www.bamsec.com/filing/147793217004400?cik=1355250
I think there are a total of 16-17-or 18
I know prior to Poly heist we had 7 or 8, and added like 10.
Recently Leo did mention in a Q that they were waiving the license fees or patent rights to some as we are strapped for cash.
Great question though and I’ll look in the K for answers.
PP. great info. I’d like to add the company came out recently in a 10-Q saying they have confirmed they OWN 100% of Prurisol rights. No profit sharing.