12-2-15 $CTIX ~ Cellceutix Corp. Due Diligence Rep

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Posted On: 12/02/2015 12:57:52 PM

Posted By: TheHound

12-2-15 $CTIX ~ Cellceutix Corp. Due Diligence Report

$CTIX recent news

PR's from Cellceutix:

http://cellceutix.com/category/press-release/...r967e.dpbs

PR's from yahoo:

Tue, 01 Dec 2015 15:31:56 GMT ~ Cellceutix Receives Rare Pediatric Disease Designation From FDA for Kevetrin for the Treatment of Retinoblastoma

[Marketwired] - Cellceutix Corporation , a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to announce that ...

read full: http://finance.yahoo.com/news/cellceutix-rece...56692.html

Mon, 30 Nov 2015 12:30:00 GMT ~ Cellceutix Retains Former Durata Executive Ronald Trust as Regulatory Affairs Consultant

[Marketwired] - Cellceutix Corporation , a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, announced today that Ronald ...

read full: http://finance.yahoo.com/news/cellceutix-reta...00164.html

Wed, 25 Nov 2015 13:00:00 GMT ~ FDA Grants Fast Track Designation to Cellceutix's Brilacidin-OM for Oral Mucositis

[Marketwired] - Cellceutix Corporation , a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to announce that ...

read full: http://finance.yahoo.com/news/fda-grants-fast...00257.html

Mon, 23 Nov 2015 12:30:00 GMT ~ Cellceutix Receives FDA Orphan Drug Designation for Kevetrin for the Treatment of Retinoblastoma

[Marketwired] - Cellceutix Corporation , a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to announce that ...

read full: http://finance.yahoo.com/news/cellceutix-rece...00762.html

Mon, 16 Nov 2015 12:30:00 GMT ~ Cellceutix Selects Docetaxel for Combination Arm in Planned Phase 2 Trial for Ovarian Cancer

[Marketwired] - Cellceutix Corporation , a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, today reports that, based ...

read full: http://finance.yahoo.com/news/cellceutix-sele...00636.html

Fri, 30 Oct 2015 11:30:00 GMT ~ Cellceutix Provides Brilacidin Update; New Class of Antibiotics to Enter Phase 3

[Marketwired] - Cellceutix Corporation , a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to provide an update ...

read full: http://finance.yahoo.com/news/cellceutix-prov...00865.html

Mon, 26 Oct 2015 11:40:04 GMT ~ Cellceutix to Request Meeting With FDA for Phase 2 Ovarian Cancer Study; Company's First-in-Human Study Defines the Pharmacokinetic Profile of Kevetrin

[Marketwired] - Cellceutix Corporation , a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to inform shareholders ...

read full: http://finance.yahoo.com/news/cellceutix-requ...04556.html

$CTIX filings - Perhaps the most important section.

http://www.sec.gov/cgi-bin/browse-edgar?compa...getcompany

$CTIX Charts

basic chart ## source: stockscores.com

$CTIX company information

## source: otcmarkets.com

Link: http://www.otcmarkets.com/stock/CTIX/company-info
Ticker: $CTIX
OTC Market Place: OTC Pink Current
CIK code: 0001355250
Company name: Cellceutix Corp.
Company website: http://www.cellceutix.com
Incorporated In: NV, USA

Additional $CTIX company information:

## source: Opinion summary from various sources.

Business Description: Cellceutix is a publicly traded company under the symbol “CTIX”. Cellceutix is a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology and antibiotic applications. Cellceutix believes it has a world-class portfolio of compounds and is now engaged in advancing its compounds and seeking strategic partnerships. Cellceutix’s anti-cancer drug Kevetrin is currently in a Phase 1 clinical trial at Harvard Cancer Centers’ Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center. This trial just completed its final cohort. Plans for a Ph 2/3 Ovarian Cancer Study are underway. In the laboratory Kevetrin has shown to induce activation of p53, often referred to as the “Guardian Angel Gene” due to its crucial role in controlling cell mutations. Cellceutix is currently conducting a Phase 2 clinical trial under Fast Track Designation with its novel compound Brilacidin-OM for the prevention and treatment of Oral Mucositis. Brilacidin-OM, a defensin mimetic compound, has shown in the laboratory to reduce the occurrence of severe ulcerative oral mucositis by more than 94% compared to placebo. Cellceutix’s anti-psoriasis drug Prurisol is presently in Phase 2 trial. Enrollment is complete. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix’s key antibiotic, Brilacidin, recently completed a successful Phase 2b trial for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Plans for a phase 3 trial are underway w/ FDA's approval. Brilacidin has the potential to be a single-dose therapy or a dosing regimen that is shorter than currently marketed antibiotics for multi-drug resistant bacteria (Superbugs). Cellceutix has formed research collaborations with world-renowned research institutions in the United States and Europe, including MD Anderson Cancer Center, Beth Israel Deaconess Medical Center, and the University of Bologna. Please click on the below link to find for more information on completed and active Human Clinical Trials.

https://www.clinicaltrials.gov/ct2/results?te...rch=Search

$CTIX share structure

## source: otcmarkets.com

Market Value: $153,621,697 a/o Nov 10, 2015
Shares Outstanding: 118,170,536 a/o Aug 26, 2015
Float: Not Available
Authorized Shares: 300,000,000 a/o May 12, 2008
Par Value: 0.0001

1) PIPELINE MILESTONES/CATALYSTS

Oncology

- Completion of K Phase 1 (Solid Tumor) -- article has been submitted to a peer review journal for publication

- Initiation of several other K Phase 2, 2/3 trials -- ovarian, pediatric retinoblastoma, pancreatic, AML... this last one w/ Bologna on hold pending financing; in future trials, K to be evaluated as a monotherapy and as a combo therapy; more frequent dosing likely (eg, 2-3x week); company pursuing outside grant support; addtl Orphan designations possible beyond the two already awarded for ovarian, pediatric retinoblastoma; more expedited pathway designations possible, e.g., Breakthrough Therapy

See:
http://www.fda.gov/downloads/AboutFDA/Centers...447162.pdf

Infectious Disease / Antibiotics

- Start of B-ABSSSI Phase 3 -- Brilacidin represents a new class of ABX, Host Defense Protein (HDP)-Mimics; given as a single dose (in Ph 2 compared favorably w/Daptomycin); two trials, approximately 1400 patients btw them; also a Pediatric Study Plan submitted to FDA for use in children; eventual Fast-Track designation, per QIDP

See:
https://en.wikipedia.org/wiki/Brilacidin

See:
http://www.researchgate.net/profile/Chandradh...8a1ca5.pdf

- Phase 2 B-OM (oral mucositis) -- FDA has granted Fast Track status; great unmet need here; recruitment ongoing, additional enrollment sites being pursued

- ABX platform progress -- advancing work on anti-fungals (Candida species, aspergillus); anti-biofilm (MTA signed for B-prophylactic testing with a Big Rx); gram-neg compounds targeting Pseudomonas, Klebsiella, E. Coli, Acinetobacter. Carbapenem-resistant Enterobacteriaceae (CRE); GI indiciations, givien B's immunomodulatory properties (Ulcerative Proctitis/Colitis, H Supportiva); topical applications for Otic Infections

Dermatology

- Phase 2 Prurisol update -- enrollment is complete (plaque psoriasis)

2) OPERATIONS

- Financing in place (shelf, Aspire)
- 1st Shareholder meeting (Dec 15)
- NASDAQ uplisting (if $2 is maintained)
- Class Action Defense (Legal/Sullivan)
- Partners: more a question of when not if as science continues to prove out -- could happen anytime. One case study, see CELG-Nurix deal (p53)

https://blogs.shu.edu/cancer/2015/09/30/ubiqu...d-celgene/

3) CURRENT TRIALS

Overall - https://clinicaltrials.gov/ct2/results?term=c...rch=Search

1. P (Phase 2, Active, not recruiting): https://clinicaltrials.gov/ct2/show/NCT024944...amp;rank=1

2. B-OM (Phase 2, recruiting): https://clinicaltrials.gov/ct2/show/NCT023243...amp;rank=3

3. K (Phase 1, Active, not recruiting): https://clinicaltrials.gov/ct2/show/NCT016640...amp;rank=4

4. B-ABSSSI (Phase 2, completed): https://clinicaltrials.gov/ct2/show/NCT020523...amp;rank=5

Abbreviations

K – Kevetrin
B – Brilacidin
P – Prurisol
OM – oral mucositis
ABSSSI – acute bacterial skin and skin structure infections
QIDP – qualified infectious disease product

Company Website:
http://www.cellceutix.com

**This section courtesy of Slcimmuno - Thanks brother!**

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