In the event anyone missed this great post:
DaubersUP Tuesday, 10/16/18 09:50:09 PM
Re: DaubersUP post# 245117 0
COMPARE FOR YOURSELF - 2012 to 2018 - IPIX $$$
AUGUST 31st 2012 - Closed at .63
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 (ABOUT 70 MILLION LESS than now)
They had ZERO CLINICAL trials - just pre-clinical work.
Some notes of accomplishments though:
Jan 2012 - Prurisol Patent Filed
March 2012 - BIDMC Agreement to test Keveterin
May 2012 - Jim Boeheim joined as advisor (lol) Jim is a good man but this was exciting at the time.
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
DESIGNATIONS: June 2012 for Prurisol - 505 (b)(2) Approach
As of OCT 16 2018
OCTOBER 16th --- Close - .18
Total OS as of AUG 27th 2018
Cash on hand: 2.4 Million
Financing in place: 22.3 MILLION available from ASPIRE
Financing in place: 75 Million Shelf Reg
Financing in place: 10 Million from MultiFamily Office
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"
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 WHEN WE PAY CRO
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
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
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:
1) QIDP Fast Track Designation ABSSSI - Dec 2014
2) Fast track Designation for OM - Nov 2015
***BREAKTHROUGH for B-OM has been applied for! Waiting on FDA - WITHIN NEXT 30 DAYS!
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
Approaching 20 CDA's with Big Pharm and other BIO's!
AUGUST 2018 --- NON-BINDING TERM SHEET SIGNED WITH GLOBAL BP for indications of B-OM and B-IBD!!!!
GOOD LUCK ALL!!!