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TheHound

11/01/17 6:26 PM

#202171 RE: sixmilliondollarbios #202161

now that's some FUNNY SHIT!

50% dilution? show us ur math.
93 million shares outstanding 9/2012.
135 million shares outstanding 9/2017.

very little pipeline progression?
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=135407422
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=134864593
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scottsmith

11/01/17 6:52 PM

#202176 RE: sixmilliondollarbios #202161

You are correct about Kevetrin -- glaciers have moved at a faster clip. The Prurisol 2a and 2b have been accomplished at a reasonable pace -- once the company actually started the trials.
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georgejjl

11/01/17 7:03 PM

#202177 RE: sixmilliondollarbios #202161

sixmilliondollarbipos

Brilacidin for OM looks compelling and I have taken a position for topline. Beyond that, a quick look at 10K's from 2012-17 show almost 50% dilution and very little pipeline progress for it. Kevetrin has essentially taken 5+ years to get move from IND to P2a. Prurisol hasn't progressed much better. Anyone care to address this red flag?



You need to really do your due diligence.

Shares sold to Aspire Capital is an investment in the future. It takes money to make money. The return on our investment will pay back extremely well in the very near future. This should not be looked at as dilution

The pipeline has really progressed especially for Prurisol and Brilacidin.


To borrow from Sox

IPIX Milestones, Clinical Trials, Recent Interviews, Corporate Overview, Patents

Upcoming Milestones



Past Milestones

Kevetrin

- Positive primary endpoint and p21 data (Phase 1)
http://www.ipharminc.com/press-release/2016/11/12/assay-results-from-cellceutix-phase-1-clinical-trial-of-kevetrin-for-cancer-show-increased-p21-expression-in-675-of-evaluable-patients

- Orphan drug designation for ovarian cancer
http://www.ipharminc.com/press-release/2016/11/16/cellceutixs-kevetrin-receives-fda-orphan-drug-designation-for-the-treatment-of-ovarian-cancer

- Orphan drug designation for pancreatic cancer
http://www.ipharminc.com/press-release/2016/11/12/cellceutix-receives-fda-orphan-drug-designation-for-kevetrin-for-the-treatment-of-pancreatic-cancer

- Orphan drug designation for retinoblastoma
http://www.ipharminc.com/press-release/2016/11/16/cellceutix-receives-fda-orphan-drug-designmation-for-kevetrin-for-the-treatment-of-retinoblastoma

- Rare pediatric disease designation for retinoblastoma
http://www.ipharminc.com/press-release/2016/11/16/cellceutix-receives-rare-pediatric-disease-designation-from-fda-for-kevetrin-for-the-treatment-of-retinoblastoma

Brilacidin

- B-UP positive top-line data (Phase 2 POC)
http://www.ipharminc.com/press-release/2017/7/13/innovation-pharmaceuticals-phase-2-poc-trial-for-inflammatory-bowel-disease-achieves-induction-of-remission-in-a-majority-of-patients-treated-with-brilacidin

- B-OM encouraging interim data (Phase 2)
http://www.ipharminc.com/press-release/2017/3/27/cellceutix-reports-very-encouraging-interim-analysis-of-phase-2-drug-candidate-brilacidin-for-severe-oral-mucositis-om-in-head-and-neck-cancer-patients-high-potential-for-preventative-treatment

- B-ABSSSI positive top-line data (Phase 2b)
http://www.ipharminc.com/press-release/2016/11/16/cellceutix-announces-positive-top-line-data-from-phase-2b-absssi-trial-single-dose-brilacidin-comparable-to-7-days-of-daptomycin

- QIDP designation for B-ABSSSI
http://www.ipharminc.com/press-release/2016/11/16/cellceutix-antibiotic-brilacidin-receives-qidp-designation-from-fda

- Fast track designation for B-OM
http://www.ipharminc.com/press-release/2016/11/16/fda-grants-fast-track-designation-to-cellceutixs-brilacidin-om-for-oral-mucositis

- MTA extension for prophylactic testing in implanted devices
http://www.ipharminc.com/press-release/2016/11/16/cellceutix-completes-lab-testing-of-brilacidin-for-planned-phase-3-trial-for-acute-bacterial-skin-and-skin-structure-infections

- Formulation stable at room temperature
http://www.ipharminc.com/press-release/2016/11/16/cellceutix-announces-breakthrough-in-the-formulation-of-novel-antibiotic-brlaicidin-plans-studies-to-treat-diabetic-foot-ulcers

- American Society for Microbiology journal publication
http://aac.asm.org/content/early/2014/06/11/AAC.02955-14#corresp-1

Prurisol

- Positive top-line data (Phase 2a)
http://www.ipharminc.com/press-release/2016/11/12/cellceutix-phase-2-trial-of-prurisol-for-mild-to-moderate-psoriasis-meets-primary-endpoint

- Positive primary endpoint (Phase 1)
http://www.ipharminc.com/press-release/2016/11/16/cellceutix-anti-psoriasis-drug-prurisol-meets-primary-endpoint-of-clinical-trial

- 505(b)(2) pathway
http://www.ipharminc.com/press-release/2016/11/17/cellceutix-informed-by-fda-that-505b2-approval-would-be-an-acceptable-approach-for-its-psoriasis-drug

Clinical Trials

1. K-OC (Phase 2a, Recruiting)
https://clinicaltrials.gov/ct2/show/NCT03042702?term=cellceutix&rank=1

2. P (Phase 1, Completed)
https://clinicaltrials.gov/ct2/show/NCT02101216?term=cellceutix&rank=2

3. B-OM (Phase 2, Active, not recruiting)
https://clinicaltrials.gov/ct2/show/NCT02324335?term=cellceutix&rank=3

4. P (Phase 2a, Completed)
https://clinicaltrials.gov/ct2/show/NCT02494479?term=cellceutix&rank=4

5. P (Phase 2b, Active, not recruiting)
https://clinicaltrials.gov/ct2/show/NCT02949388?term=cellceutix&rank=5

6. B-ABSSSI (Phase 2b, Completed)
https://clinicaltrials.gov/ct2/show/NCT02052388?term=cellceutix&rank=6

7. K (Phase 1, Completed)
https://clinicaltrials.gov/ct2/show/NCT01664000?term=cellceutix&rank=7

8. B-UP (Phase 2 POC, Completed)
http://www.ipharminc.com/press-release/2016/11/10/cellceutix-receives-update-on-first-patient-enrollment-in-phase-2-proof-of-concept-study-of-brilacidin-for-ulcerative-proctitis

Pipeline



Recent Interviews

- 2017 Q3 Conference Call Transcript
https://seekingalpha.com/article/4080068-innovation-pharmaceuticals-ipix-ceo-leo-ehrlich-q3-2017-results-earnings-call-transcript

- 2017 Q1 Conference Call Transcript
http://seekingalpha.com/article/4023682-cellceutix-corporation-ctix-ceo-leo-ehrlich-q1-2017-results-earnings-call-transcript

- Interview with New Cellceutix President Dr A Bertolino
http://seekingalpha.com/article/3988240-interview-new-cellceutix-president-dr-bertolino

- Cellceutix Pipeline Continues to Hit Milestone After Milestone
https://www.streetwisereports.com/pub/na/cellceutix-pipeline-continues-to-hit-milestone-after-milestone

- A Small-Cap Biotech with Big Ideas for Acute Infections and Cancers: Cellceutix's Leo Ehrlich and Dr. Daniel Jorgensen
http://www.thelifesciencesreport.com/pub/na/a-small-cap-biotech-with-big-ideas-for-acute-infections-and-cancers-cellceutixs-leo-ehrlich-and-dr-daniel-jorgensen

Corporate Overview

- BioCentury NewsMakers Conference https://static1.squarespace.com/static/5715352e20c647639137f992/t/59b2f34946c3c498ebfe112e/1504899917915/IPIX+Company+Presentation+BioCentury+NewsMakers+Conference++8Sep2017.pdf

- Drug Discovery and Therapy World Congress
https://static1.squarespace.com/static/5715352e20c647639137f992/t/596cac7df14aa1a6e7118ed8/1500294274057/IPI+DDTWC+Brilacidin+presentation+%28final-u%29+13Jul2017.pdf

- July 2017
https://static1.squarespace.com/static/5715352e20c647639137f992/t/5967d1c92994ca6bed362ade/1499976142099/2017+July+IPIX+Corporate+Overview.pdf

Patents

- Kevetrin
https://www.google.com/patents/US8338454

- Brilacidin
https://www.sec.gov/Archives/edgar/data/1355250/000147793214002418/ctix_ex1037.htm
https://www.google.com/patents/US20160243117
https://www.google.com/patents/EP2709619A2

- Prurisol
https://www.google.com/patents/WO2013103601A1

MP Advisors Report

https://drive.google.com/file/d/0Bz15O4eaX-asWVpoclB2WUhENFk/view

Abbreviations

K – Kevetrin
B – Brilacidin
P – Prurisol
OC – ovarian cancer
ABSSSI – acute bacterial skin and skin structure infections
OM – oral mucositis
UP – ulcerative proctitis
QIDP – qualified infectious disease product

GOD bless,

George
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DaubersUP

11/01/17 9:03 PM

#202200 RE: sixmilliondollarbios #202161

40 million to achieve all of this is very very very good. I'm not sure what planet you live on where this is not progress: also we went from like 8 or 9 drugs to 17ish in that time.
I mean come on man. You say you were in from 12 -15 and you question the progress. 5 successful clinical trials and 3 mid stage trials about to release data. I know companies that went over 200 million on one drug and reverse split and in the end the drug failed. Leo has played this brilliantly.


IPIX Clinical Trial Timelines

2012
1. Kevetrin (Phase 1)

2013
1. Kevetrin (Phase 1)

2014
1. Kevetrin (Phase 1)
2. Brilacidin-ABSSSI (Phase 2b)
3. Prurisol (Phase 1)

2015
1. Kevetrin (Phase 1)
2. Brilacidin-ABSSSI (Phase 2b, Successful)
3. Prurisol (Phase 1, Successful)
4. Brilacidin-OM (Phase 2)
5. Prurisol (Phase 2a)

2016
1. Kevetrin (Phase 1, Successful)
2. Brilacidin-ABSSSI (Phase 2b, Successful)
3. Prurisol (Phase 1, Successful)
4. Brilacidin-OM (Phase 2)
5. Prurisol (Phase 2a, Successful)
6. Brilacidin-UP (Phase 2 POC)
7. Prurisol (Phase 2b)
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sox040713

11/01/17 9:46 PM

#202211 RE: sixmilliondollarbios #202161

K Phase 1 ended with the best scenario for the primary outcome. The trial concluded with the MAD (750 mg/m2) as the MTD. Eight more patients had to be recruited due to its safety profile.

Pharmacyclics' Imbruvica also took four years to complete Phase 1. Such is life in oncology trials. Not a red flag.

Kevetrin has essentially taken 5+ years to get move from IND to P2a.


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MinnieM

11/02/17 12:10 AM

#202223 RE: sixmilliondollarbios #202161

Brilacidin certainly does look compelling. It’s what keeps me holding since it’s as close to a sure thing that one can get in high risk biotech.

Regarding the dilution, I’m ok with it because it hasn't been excessive and we’ve made good progress with trials along with purchasing the PolyMedix assets. All of this was done without an r/s.

There’s no doubt that the Kevetrin ph1 was a slow one. But, I think that they were forced to start out at low dosages for several reasons. First of all, the poor safety history of previous p53 drugs had to give the FDA pause when looking at approving this trial. The patients were stage 4 cancer patients and needed to be treated with care. Approval was needed before progressing from one cohort to the next.

Then, you had competing oncology trials at Dana Farber. It was surprisingly slow in recruiting. As a matter of fact, this experience of competing trials is likely the reason that the company decided against running the Brilacidin ph2 Oral Mucositis trial at MD Anderson. They’d already been burnt with slow recruitment at a location with competing trials. The relationship between Dr Fried and Dr Menon is likely the primary reason Kevetrin ended up at Dana Farber.

A Prurisol trial was set to start and canceled due to the purchase of the Brilacidin assets. I suspect that they put it on hold until they had a chance to see what direction they wanted to move in after this asset purchase. They likely had an idea of tweaking Brilacidin for lower dosages but, probably had no idea what it would actually cost until playing with it in hand for a bit.

The Prurisol ph2a psoriasis trial completed ahead of schedule. The only mistake I see that Leo made here was building expectation of an interim and then deciding against it. They reasoning may have been sound, but, it was poorly communicated.

But, as I’ve always said, I don’t always agree with his communication style. Management isn’t perfect, but, they’ve done a great job moving forward with trials under less than optimal circumstances.

I still believe we’d be much further ahead with the science and more patients would have been dosed by now if it weren’t for being slammed with the distorted hit pieces in 2015.

Look at the chart while viewing the following dates:
1.2.15 Sharvey
1.23.15 Bleecker
2.6.15 Bleecker
8.6.15 Mako followed by Rosen lawsuit based on this attack. Suit was dismissed, but, not until 2016. By then, the damage was done. And, being from Wall Street as you say in another post, you should understand this game. Perception is more important than reality at times. The name became mud.

As price went down it was more dilutive to raise capital. Uplist was derailed. But, more importantly, these delays may have hurt potential patients. I believe these attacks contributed to a high degree in the Brilacidin ph3 ABSSSI delay. Some things still are all about money.

I don't see a major break to upside in price until a partner is onboard. And, having met both Dr Menon and Leo twice now, I have to believe them when they say they are actively seeking a partner at this point. Plus, the SEC filings state they have confidentiality agreements signed. I doubt they'd lie in a filing to the SEC. I'm just glad they have progressed the trials far enough to do so.

Anyway, good luck with your new purchase.








In Reply to 'sixmilliondollarbios'
Question for the board..

Brilacidin for OM looks compelling and I have taken a position for topline. Beyond that, a quick look at 10K's from 2012-17 show almost 50% dilution and very little pipeline progress for it. Kevetrin has essentially taken 5+ years to get move from IND to P2a. Prurisol hasn't progressed much better. Anyone care to address this red flag?

Disclosure: I was quite familiar with CTIX, in and out numerous times going back to 2012-15. Since then I have occasionally glanced at the ticker. Needless too say I have not been impressed with the progress here.