Friday, April 28, 2017 12:59:51 PM
A comparison to PART I which was when the share price was around .65 - 1.00 back in summer of 2012. This PART II will give brief facts compared to PART I (4+ Year difference)
April 27th 2017 - Share closed at .7199
Cash on Hand from 10-Q ending Dec 31st 2016 - 3.9 Million (Plus the 2.2 Million from the 3/31 PIPE) so about 6.1 Million (COMPARE THAT TO $27,000 Cash on hand in 2012)
FINANCING AVAILABLE: Approx $19 Million from Aspire was available per 10-Q as of Dec 31st 2016 (In 2012 there was no funding available at the time the share price was the same as today)
SHELF REG: $45 million available under the Company’s effective shelf registration statement. This was filed March 31st 2015 (WAS NOT AVAIL in 2012)
CURRENT OS: January 27, 2017 -
126,408,756
Add the PIPE of 2,471,912 - so Approx - 129 Million OS (Compared to approx 93 MILLION SEPT 30th 2012)
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: IN PROGRESS Estimated July 2017)
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: IN PROGRESS Estimated Dec 2017)
Interim Data - Patients swishing B 3x a day developed Sever OM 22.2% compared to the Placebo arm that developed severe OM 70% (THERE IS NO CURRENT SOC FOR PREVENTING OM)
7) A Phase 2 Study of Kevetrin in Subjects With Ovarian Cancer
(Start: Feb 2017 - End: IN PROGRESS Estimated Dec 2017)
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: IN PROGRESS Estimated 1H 2017) (weeks)
The share price in Aug-Sept 2012 was above current share price and there were ZERO clinical trials at that point. AGAIN LOOK ABOVE AT WAS HAS BEEN COMPLETED SINCE THEN
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
The only FDA designation that CTIX had in 2012 when the share price was between .60-1.00 was from June 2012 for Prurisol - 505 (b)(2) Approach
CURRENT PIPELINE IMAGE:
https://static1.squarespace.com/static/5715352e20c647639137f992/t/5835f4b020099ed326eed244/1479931063630/?format=1500w
ADDITIONAL HIRES:
Dr. Arthur P. Bertolino - President and CMO
LaVonne Lang - VP Regulatory Affairs
Jane Harness - VP Clinical Sciences
COMPOUNDS OWNED BY CTIX in 2012: 8 TOTAL
Kevetrin
KM 133
KM 391
KM 277
KM 278
KM 362
KM-3174
KM-732
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"
SO AGAIN MY FRIENDS!!! We are sitting at or below the share price in 2012 where, yes we have added about 40 million to the OS - BUT does that increase really justify the share price to stay the same as we note the progress that has been made over those 4+ years? GET READY FOR A CORRECTION SOON!!! GO CTIX!!!!
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- Form 8-K - Current report • Edgar (US Regulatory) • 10/30/2023 08:15:25 PM
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