CARDAX, INC. (OTCMKTS:CDXI) Files An 8-K Regulation FD Disclosure
ITEM 7.01 REGULATION FD DISCLOSURE
On September 23, 2019, Cardax, Inc. (the “Company”) issued a press release announcing the interim results of its human clinical trial with ZanthoSyn®, the Company’s astaxanthin dietary supplement.
In accordance with General Instruction B.2 of Form 8-K, the information set forth herein and in Exhibit 99.1 hereto is deemed to be “furnished” and shall not be deemed to be “filed” for purposes of the Exchange Act. The information set forth in Item 7.01 of this Current Report on Form 8-K shall not be deemed an admission as to the materiality of any information in this Current Report on Form 8-K that is required to be disclosed solely to satisfy the requirements of Regulation FD.
Safe Harbor
This release may contain certain forward-looking statements regarding our prospective performance and strategies within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995, and are including this statement for purposes of said safe harbor provisions. Forward-looking statements, which are based on certain assumptions and describe future plans, strategies, and expectations of our company, are generally identified by use of words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “project,” “seek,” “strive,” “try,” or future or conditional verbs such as “could,” “may,” “should,” “will,” “would,” or similar expressions. Our ability to predict results or the actual effects of our plans or strategies is inherently uncertain. Accordingly, actual results may differ materially from anticipated results. Some of the factors that could cause our actual results to differ from our expectations or beliefs include, without limitation, the risks discussed from time to time in our filings with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Except as required by applicable law or regulation, we undertake no obligation to update these forward-looking statements to reflect events or circumstances that occur after the date on which such statements were made.
Forward-looking statements made also include, but are not limited to, statements regarding the development and potential applications of our products and product candidates, including our discussion of clinical trial interim results, which are not necessarily indicative of final results. The interim results described in this press release do not ensure that the final results of the CHASE clinical trial or other clinical trials will be positive or statistically significant or clinically meaningful. Our characterization of the CHASE clinical trial interim results in this press release as encouraging and promising and that pleiotropic effects, excellent safety, and beneficial changes in markers of cardiovascular health were demonstrated in such interim review are forward-looking statements and may not be replicated by the final results of the CHASE clinical trial or other clinical trials. The p-values reported herein are nominal p-values from non-parametric comparisons of the median between each group and placebo and no adjustments for multiple comparisons were made. There can be no assurance that we will successfully develop or commercialize our products or product candidates or that these interim results will adequately support additional intellectual property protection. In summary, our ability to predict results or the actual effects of our plans or strategies are inherently uncertain.
ITEM 9.01 FINANCIAL STATEMENT AND EXHIBITS
(d) Exhibits.
| 99.1 | Press Release, dated September 23, 2019 (furnished herewith) |
CARDAX, INC. Exhibit
EX-99.1 2 ex99-1.htm Cardax Announces Interim Results from CHASE Clinical Trial Pre-Specified Interim Review Demonstrated Beneficial Changes in Markers of Cardiovascular Health – CRP,…
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About CARDAX, INC. (OTCMKTS:CDXI)
Cardax, Inc. is a life sciences company. The Company develops consumer health and pharmaceutical technologies. The Company is engaged in developing and commercializing anti-inflammatory dietary supplements and drugs. The Company offers ZanthoSyn, a product to help consumers address their inflammatory health. ZanthoSyn is an astaxanthin dietary supplement distributed by the Company. ZanthoSyn features synthetic astaxanthin. Astaxanthin is an ingredient with anti-inflammatory activity that supports joint health, cardiovascular health, metabolic health and liver health. As of December 31, 2015, the Company had two other anti-inflammatory programs with application in various markets, including zeaxanthin esters for macular degeneration and hepatic disease, and lycophyll esters for prostate disease.
