Zeo ScientifiX, Inc 8-K, filed May 19, 2020
Zeo ScientifiX, Inc. (ZEOX)
About this 8-K
Zeo ScientifiX, Inc filed this 8-K on May 19, 2020.
Items reported
- Item 3.02: Unregistered sale of equity
- Item 5.02: Director or officer change, or executive pay
- Item 8.01: Other events
- Item 9.01: Financial statements and exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934
Date of report (Date of earliest event reported): May 19, 2020
ORGANICELL REGENERATIVE MEDICINE, INC.
(Exact name of registrant as specified in its charter)
| Nevada | 000-55008 | 47-4180540 |
| (State or Other Jurisdiction | (Commission File Number) | (IRS Employer |
| of Incorporation) | Identification No.) |
4045 Sheridan Avenue, Suite 239, Miami, FL 33140
(Address of Principal Executive Offices) (Zip Code)
Registrant's telephone number, including area code: (888) 963-7881
_________________________________________________
(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 | Name of each exchange on which registered |
| None | N/A | N/A |
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 mark 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. ☐
As used in this Current Report on Form 8-K, and unless otherwise indicated, the terms “the Registrant”, “the Company,” “Organicell,” “we,” “us” and “our” refer to Organicell Regenerative Medicine, Inc.
| Item 3.02 | Unregistered Sales of Equity Securities. |
The disclosure set forth in Item 5.02 of this report is incorporated herein in its entirety by reference.
| Item 5.02 | Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. |
In connection with the terms of the Company’s Management and Consultant Performance Plan (“MCPP”) previously described in the Company’s Form 8-K filed on April 30, 2020, the Company issued newly issued common stock of the Company to the following individuals as a result of the Company successfully achieving a total of three of the operational milestones (“Milestones”) as defined in the MCPP, which were based on the Company receiving approvals by the U.S. Food and Drug Administration (FDA) of three Investigational New Drug (IND) applications for its lead product, Organicell Flow, for patients diagnosed with moderate to severe acute respiratory syndrome (SARS) due to COVID-19 infection (see previous disclosure contained in the Company’s Form 8-K filed on May 5, 2020) and the disclosure in Item 8.01 of this report below:
| Mr. Albert Mitrani | 23,000,000 Shares | |
| Mr. Ian Bothwell | 23,000,000 Shares | |
| Dr. Maria Mitrani | 23,000,000 Shares | |
| Dr. George Shapiro | 23,000,000 Shares | |
| Consultant | 12,000,000 Shares |
The Company issued the above-referenced Shares under the exemption from the registration requirements of the Securities Act afforded by Section 4(a)(2) of the Securities Act, as a transaction not involving a public offering.
| Item 8.01 | Other Events. |
On May 19, 2020, Organicell issued a press release in which it announced the approval by the U.S. Food and Drug Administration (FDA) of two emergency compassionate use Investigational New Drug (eIND) applications for its lead product, Organicell Flow, each for a single patient severely ill from COVID-19.
A copy of the Company’s press release dated May 19, 2020 is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
| Item 9.01 | Financial Statements and Exhibits |
(d) Exhibits
| Exhibit No | Description | |
| 99.1 | Press Release, dated May 19, 2020 |
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SIGNATURES
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.
| Dated: May 19, 2020 | ORGANICELL REGENERATIVE MEDICINE, INC. | |
| By: | /s/ Ian Bothwell | |
| Ian Bothwell Chief Financial Officer | ||
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Exhibit 99.1
FDA Approves Two Emergency INDs to Administer Organicell Flow for COVID-19
First Patients treated with Organicell Flow through “Emergency Single Patient Compassionate Use” designation
Miami, FL (May 19, 2020) – Organicell Regenerative Medicine, Inc. (OTCBB:BPSR), a clinical-stage biopharmaceutical company dedicated to the development of regenerative therapies, announced today that on May 11, 2020, the U.S. Food and Drug Administration (FDA) authorized two Emergency Compassionate Use Investigational New Drug applications (eINDs), each for a single patient severely ill from COVID-19. These critical patients have received immediate administration of Organicell Flow.
Organicell is collaborating with physicians at Landmark Hospital, a network of six hospitals located throughout the Southeast United States, to treat these patients for advanced complications associated with COVID-19. These patients were first treated with Organicell Flow on May 14, 2020 at Landmark Hospital in Athens, GA.
“These two patients who did not meet our Phase I/II inclusion criteria from our previously approved IND will now have the opportunity to get immediate treatment with Organicell Flow under the FDA’s approved eIND,” said Dr. Mari Mitrani, Chief Science Officer at Organicell. “We look forward to working with our partners at Landmark Hospital to try to help these critically ill patients.”
On May 5, 2020, Organicell previously announced plans to begin the first randomized, double-blinded, placebo-controlled, phase I/II multi-center clinical trial of Organicell Flow, investigating the safety and potential efficacy of amniotic fluid sourced components for COVID-19. It is expected that this trial will begin enrollment later in the month. Find the listing of the Organicell Flow clinical trial here: https://clinicaltrials.gov/ct2/show/NCT04384445?term=Organicell&draw=2&rank=1
“I’m extremely proud of what the Organicell team has accomplished since we first started working on this virus in January. We are excited to now be in a position to help patients that are suffering from this horrible disease,” said Albert Mitrani, Chief Executive Officer at Organicell.
About Organicell Regenerative Medicine, Inc.:
Organicell Regenerative Medicine, Inc. is a clinical-stage biopharmaceutical company that harnesses the power of exosomes to develop innovative biological therapeutics for the treatment of degenerative diseases. The company’s proprietary products are derived from perinatal sources and manufactured to retain the naturally occurring exosomes, hyaluronic acid, and proteins without the addition or combination of any other substance or diluent. Based in South Florida, the company was founded in 2008 by Albert Mitrani, Chief Executive Officer and Dr. Mari Mitrani, Chief Scientific Officer. To learn more, please visit https://organicell.com/.
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Forward-Looking Statements
Certain of the statements contained in this press release should be considered forward-looking statements within the meaning of the Securities Act of 1933, as amended (the “Securities Act”), the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are often identified by the use of forward-looking terminology such as “will,” “believes,” “expects,” “potential” or similar expressions, involving known and unknown risks and uncertainties. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, they do involve assumptions, risks and uncertainties, and these expectations may prove to be incorrect. We remind you that actual results could vary dramatically as a result of known and unknown risks and uncertainties, including but not limited to: potential issues related to our financial condition, competition, the ability to retain key personnel, product safety, efficacy and acceptance, the commercial success of any new products or technologies, success of clinical programs, ability to retain key customers, our inability to expand sales and distribution channels, legislation or regulations affecting our operations including product pricing, reimbursement or access, the ability to protect our patents and other intellectual property both domestically and internationally and other known and unknown risks and uncertainties, including the risk factors discussed in the Company's periodic reports that are filed with the SEC and available on the SEC's website (http://www.sec.gov). You are cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by these risk factors. Specific information included in this press release may change over time and may or may not be accurate after the date of the release. Organicell has no intention and specifically disclaims any duty to update the information in this press release.
Media Contact:
RooneyPartners
Marion Janic
646-537-5649
mjanic@rooneyco.com
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