UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 13, 2020
JUPITER WELLNESS, INC.
(Exact name of registrant as specified in charter)
| Delaware | 001-39569 | 83-2455880 | ||
| (State or other jurisdiction | (Commission | (IRS Employer | ||
| of incorporation) | File Number) | Identification No.) |
725 N. Hwy A1A, Suite C-106 Jupiter, FL 33477
(Address of principal executive offices) (Zip Code)
(561) 244-7100
(Registrant’s telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| [ ] | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| [ ] | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| [ ] | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| [ ] | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
| Common Stock | JUPW |
The Nasdaq Stock Market LLC (The Nasdaq Capital Market)
| ||
| Warrants, each exercisable for one share of Common Stock at $8.50 per share | JUPWW |
The Nasdaq Stock Market LLC (The Nasdaq Capital Market) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company [ ]
If an emerging growth company, indicate by check mart if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [ ]
Item 7.01 Regulation FD Disclosure
On November 13, 2020 Jupiter Wellness, Inc. issued the attached press release. A copy of the press release is attached hereto and incorporated herein by reference in its entirety as Exhibit 99.1.
Item 9.01 Financial Statements and Exhibits
Exhibits
| Exhibit No. | Description | |
| 99.1 | Press release, dated November 13, 2020 |
| 1 |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: November 13, 2020
| JUPITER WELLNESS, INC. | ||
| By: | /s/ Brian John | |
| Brian John | ||
| Chief Executive Officer | ||
| 2 |
Jupiter Wellness Initiates Clinical Trial for CaniDermRx in the Treatment of First Degree Burns
Study data to be used in planned IND filing with U.S. FDA
Jupiter, FL – Accesswire - November 13, 2020 - Jupiter Wellness, Inc. (Nasdaq: JUPW), a leading developer of cannabidiol (CBD) based medical therapeutics and wellness products, today announced it has initiated an exploratory clinical study of CaniDermRx, its prescription topical cream candidate which combines CBD and aspartame as its active ingredients, in the treatment of first degree burns. While no double-blind, randomized controlled study has demonstrated efficacy of a CBD-aspartame product in the treatment of burns to Jupiter’s knowledge, CaniDermRx may be effective in this indication based on its dual mechanisms of action. Since, cannabinoid receptor I (CB1R) is known to be rapidly expressed in mononuclear and fibroblastic cells following skin wounding, and aspartame has been found to induce angiogenesis in-vitro and in-vivo, Jupiter believes that CaniDermRx may accelerate burn wound healing compared to products currently on the market.
The double blind, placebo controlled study’s protocol is in line with U.S. Food and Drug Administration (FDA) Phase I studies and will recruit an estimated 50 patients through clinical sites in Europe and Asia. Subjects will be first-degree burn patients newly diagnosed with superficial partial thickness burns on 10% or less of the total body surface area. The primary endpoint of the study is time to full re-epithelialization of the wound.
“We are pleased to commence this clinical study in what is now our second indication for our CBD-based prescription therapeutic candidate CaniDermRx. As the number of burn cases is increasing worldwide, we are eager to explore the healing potential of CaniDermRx’s dual mechanisms of action for this patient population. Data resulting from the study would be included in an Investigational New Drug (IND) application that we intend to file with the FDA for Phase I or II studies in the U.S.,” stated Jupiter CEO Brian John.
About Jupiter Wellness
Jupiter Wellness, Inc. (NASDAQ: JUPW) is a leading developer of cannabidiol (CBD)
based medical therapeutics and wellness products. The Company’s clinical pipeline of prescription CBD-enhanced skin care
therapeutics address indications including eczema, burns, herpes cold sores, and skin cancer. Jupiter generates revenues from a
growing line of proprietary over-the-counter skincare products including its flagship CaniSun™ sunscreen and other wellness
brands sold through its robust distribution platform.
For additional information, please visit www.jupiterwellnessinc.com. The Company’s public filings can be found at www.Sec.gov.
Safe
Harbor Statement
To the extent any statements contained in this presentation of Jupiter Wellness, Inc. (the “Company”) contains
“forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 and the information
that are based upon beliefs of, and information currently available to, the company’s management as well as estimates and
assumptions made by the company’s management. These statements can be identified by the fact that they do not relate strictly
to historic or current facts. When used in this presentation the words “estimate,” “expect,” intend,”
believe,” plan,” “anticipate,” “projected” and other words or the negative of these terms and
similar expressions as they relate to the company or the company’s management identify forward-looking statements. Such statements
reflect the current view of the company with respect to future events and are subject to risks, uncertainties, assumptions and
other factors relating to the company’s industry, its operations and results of operations and any businesses that may be
acquired by the company. Should one or more of these risks or uncertainties materialize, or the underlying assumptions prove incorrect,
actual results may differ significantly from those anticipated, believed, estimated, expected, intended, or planned. Although the
company believes that the expectations reflected in the forward-looking statements are reasonable, the company cannot guarantee
future results, performance, or achievements. Except as required by applicable law, including the security laws of the United States,
the company does not intend to update any of the forward-looking statements to conform these statements to actual results.
Investor & Public Relations Contact Info
Phone: 561-244-7100
Email: info@jupiterwellnessinc.com