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Wednesday, March 14, 2018 11:20:55 AM
COMPARE FOR YOURSELF - 2012 to 2018 - IPIX $$$
September 31st 2012 - Closed at 1.00
In the 10-K released on 10/12/12 I found the below info. Here is link to 10-K (https://www.bamsec.com/filing/154823312000017?cik=1355250)
CASH ON HAND - $27,000
CTIX did not have any major Stock Purchase Agreements at the time! So no funds readily available.
OS as of SEPT 30th 2012 - - 93,124,151
They had ZERO CLINICAL trials - They were starting Kevetrin Phase 1 at the end of 2012 at Dana Farber Harvard and partners.
Some notes of accomplishments though:
Jan 2012 - Prurisol Patent Filed
March 2012 - BIDMC Agreement to test Keveterin
June 2012 - IND Meeting with FDA approved to seek section 505(b)(2)
June 2012 - IND approved by FDA to begin Phase 1 trial at Dana Farber and BIDMC for Keveterin
Sept 2012 - Selected Dr. Reddy's Lab to manufacturer P
COMPOUNDS OWNED BY CTIX in 2012: 8 TOTAL
Kevetrin
KM 133
KM 391
KM 277
KM 278
KM 362
KM-3174
KM-732
DESIGNATIONS: June 2012 for Prurisol - 505 (b)(2) Approach
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FAST FORWARD ----- As of March 5th 2018 -----------
March 5th Close - .55
Total OS as of Jan 31st 2018 ----- 145,688,782 shares
Cash on hand: 3.2 Million
Financing in place: 25.6 MILLION available from ASPIRE
Financing in place: 75 Million Shelf Reg
Compounds Owned in 2018:
ADDITIONAL COMPOUNDS OWNED AFTER POLYMEDIX's acquisition: 18 TOTAL
**THIS INCLUDES PATENTS** It also included "SUBSTANTIAL EQUIPMENT ASSETS"
"We are very excited about instantly having a strong antibiotic franchise to complement our already robust pipeline that now contains 18 compounds"
ACCOMPLISHMENTS:
CLINICAL TRIALS: (Daubs summary)
1) PHASE I: A Safety, Pharmacokinetic and Pharmacodynamic Study of Kevetrin in Patients With Advanced Solid Tumors
(Start: Oct 2012 - End: Feb 2016) SUCCESSFUL
2) PHASE 2B: Efficacy and Safety Study of Brilacidin to Treat Serious Skin Infections
(Start: Feb 2014 - END: Oct 2014) SUCCESSFUL
***Compared favorably to Daptomycin which is a blockbuster drug
3) PHASE I: Bioequivalence and Pharmacokinetic Study of Prurisol™ and Abacavir Sulfate in Healthy Volunteers
(Start: March 2014 - End: Oct 2014) SUCCESFUL
4) PHASE II: Efficacy and Safety of Prurisol Administered Orally for Active Mild to Moderate Chronic Plaque Psoriasis
(Start: Aug 2015 - End: May 2016) SUCCESSFUL
5) PHASE 2B: Efficacy and Safety of Prurisol Administered Orally for Active Moderate to Severe Chronic Plaque Psoriasis
(Start: Oct 2016 - End: Dec 2017) TOP LINE DATA IN WEEKS
6) PHASE 2: Study of the Effects of Brilacidin Oral Rinse on Radiation-induced Oral Mucositis in Patients With Head and Neck Cancer (Brilacidin)
(Start: May 2015 - End: Dec 2017) SUCCESSFUL
MGMT COMMENT:
After a recent successful Phase 2 trial in Oral Mucositis (OM), the Company believes that it is the clear global leader in this area as it develops an easy-to-administer oral rinse medicine for the prevention of severe Oral Mucositis (SOM) in Head and Neck Cancer (HNC) patients receiving chemoradiation—analysts estimate this market could reach $1 billion in coming years.
7) A Phase 2 Study of Kevetrin in Subjects With Ovarian Cancer
(Start: Feb 2017 - End: Feb 2018) SUCCESSFUL
8) A Phase 2 open label Proof-of-Concept trial evaluating Brilacidin as a new treatment for mild-to-moderate ulcerative proctitis/ulcerative proctosigmoiditis, two types of inflammatory bowel disease
(Start: June 2016 - End: June 2017) SUCCESSFUL
DESIGNATIONS FROM THE FDA:
Brilacidin -
1) QIDP Fast Track Designation ABSSSI - Dec 2014
2) Fast track Designation for OM - Nov 2015 (The company just released if the final OM results are on par with interim they will apply for BREAKTHROUGH DESIGNATION)
KEVETRIN -
3) Orphan Drug Designation for Ovarian Cancer - July 2015
4) Orphan Drug Designation for Retinoblastoma - Nov 2015
5) Rare Pediatric Disease Designation for Retinoblastoma - Nov 2015
(the case for Silver Spring-based United Therapeutics Corp., which sold a voucher for $350 million in 2015)
*Orphan Drug Designation for Pancreatic Cancer - Jan 2016
6) BREAKTHROUGH for B-OM has been applied for! Waiting on FDA (My opinion)
Approaching 20 CDA's with Big Pharm and other BIO's!
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READ THE ABOVE WHICH ARE FACTS AND CAN BE FOUND USING THE COMPANY WEBSITE and THE SEC! FACTS
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