On November 14, 2019 Cardax, Inc. (OTCQB:CDXI) reported that results for the third quarter of 2019 (Press release, Cardax Pharmaceuticals, NOV 14, 2019, View Source [SID1234551333]). Highlights were as follows:
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
CHASE Clinical Trial. On September 23, 2019, the Company announced results from the pre-specified interim review of its ongoing CHASE (Cardiovascular Health Astaxanthin Supplement Evaluation) clinical trial.
The CHASE clinical trial is a double-blind, randomized, placebo-controlled clinical trial evaluating the effect of the Company’s astaxanthin dietary supplement ZanthoSyn, on cardiovascular health, as measured by C-Reactive Protein or "CRP" levels over 12 weeks in up to 120 subjects with documented cardiovascular risk factors. Pre-specified secondary cardiovascular/inflammatory health markers, safety parameters, exploratory endpoints, and pre-specified sub-groups are also being assessed. The trial includes an optional open-label extension through 48 weeks.
The interim results were based on data from 40 subjects administered high dose ZanthoSyn (96 mg/day astaxanthin—48 mg twice a day), low dose ZanthoSyn (24 mg/day astaxanthin—12 mg twice a day), or placebo. The Company believes these encouraging findings provide:
Further mechanistic support for the Company’s astaxanthin pharmaceutical development program
Basis for additional patent filings
Support for the cardiovascular health benefits of ZanthoSyn*
View press release: Cardax Announces Interim Results from CHASE Clinical Trial, September 23, 2019
Intellectual Property. The Company filed additional patents to extend patent coverage in the U.S. and worldwide to 2039-2040, with such applications including coverage related to certain cardiovascular uses on the basis of the CHASE clinical trial results as well as coverage related to the composition of matter of CDX-101, the Company’s lead pharmaceutical candidate.
ZanthoSyn. Revenues rebounded in Q3 2019 with a more than five times increase compared to the previous quarter: $229,142 in Q3 2019 vs. $45,391 in Q2 2019. The rebound was driven by a return to normal inventory sell-in patterns, where "sell-in" is defined as wholesale orders of ZanthoSyn by General Nutrition Corporation ("GNC") less sales incentives, promotions, discounts, and refunds. Sell-through (retail sales of ZanthoSyn to GNC customers) also continued strong and the Company expects this trend to continue. ZanthoSyn is the top-selling product nationwide in GNC’s antioxidant category for 2019 year-to-date as well as the top-selling overall product in GNC’s Hawaii stores.
Financing. The Company raised $1,390,000 since the beginning of Q3 2019 to date, primarily via convertible notes, with the majority of this amount to automatically convert to equity upon a qualified financing of $5,000,000 or more. Net proceeds are being used for general working capital and to fund research, development, and clinical programs.
"We are very pleased with the encouraging CHASE trial interim results and our new patent filings. These milestones reflect the successful execution of key parts of our strategy to create value around our pharmaceutical development programs," said David G. Watumull, Cardax President and CEO. "On the consumer side of the business, the rebound in ZanthoSyn sales in Q3 2019 serves as an excellent foundation for Q4 2019 and Q1 2020."