8-K - ORGS - Equibles

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): October 15, 2021

ORGENESIS

INC.

(Exact name of registrant as specified in its charter)

Nevada	001-38416	98-0583166
(State<br> or other jurisdiction	(Commission	(IRS<br> Employer
of<br> incorporation	File<br> Number)	Identification<br> No.)

20271Goldenrod Lane, Germantown, MD 20876

(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code: (480) 659-6404

NotApplicable

(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:

☐	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<br> Stock	ORGS	The<br> Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in 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 checkmark 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. ☐

Item7.01 Regulation FD Disclosure.

Attached to this Current Report on Form 8-K as Exhibit 99.1 is a copy of the transcript of an investor video at the following link: https://www.youtube.com/watch?v=VsOu4UOjhMs, which will be used by Orgenesis Inc. on its website and in presentations to investors.

The information under this Item 7.01, including the exhibit attached hereto, is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, except as expressly set forth by specific reference in such filing.

Exhibit<br> No.	Description
99.1	Transcript<br> of investor video
104	Cover Page Interactive Data File (embedded within the<br> Inline XBRL document)

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.

	ORGENESIS INC.
Date:<br> October 15, 2021	By:	/s/ Neil Reithinger
		Neil<br> Reithinger
		Chief<br> Financial Officer, Treasurer and Secretary

Exhibit 99.1

Transcript of video at https://www.youtube.com/watch?v=VsOu4UOjhMs:

Orgenesis is a global biotech company working to unlock the full potential of cell and gene therapies (CGTs) in an affordable and accessible format at the point of care. CGTs are among the fastest growing sectors in medicine, but the currently approved products can cost hundreds of thousands of dollars per patient and rely on manual processes in cleanrooms that are not easy to scale. In order to make these therapies accessible to all, we created a new cell and gene therapy value chain from research and licensing through clinical trials, processing, to distribution at the point of care. The Orgenesis POCare Platform is comprised of three enabling components. A pipeline of licensed therapeutics that are processed and produced in closed, automated Technology systems across a collaborative Network. Orgenesis identifies promising new therapies and leverages its POCare Platform to provide a rapid, globally harmonized pathway for these therapies to reach and treat large numbers of patients at lowered costs through efficient, scalable, and decentralized production. The POCare Network brings together patients, doctors, industry partners, research institutes and hospitals worldwide to achieve harmonized, regulated clinical development and production of therapies. Orgenesis advances in-house research programs collaborating with primary investigators from leading research institutions and hospitals. A global network provides access to the most innovative technologies and therapies across the ecosystem. This solution allows us to quickly expand capacity in existing and new sites. Our goal is to create the most efficient value chain for advanced therapies, making them accessible to millions of patients across the globe rapidly and at an affordable cost. We integrate these combined solutions into a mobile biotech processing unit – The Orgenesis Mobile Processing Unit and Labs, or OMPUL. This is a mobile unit with the required biosafety classifications that allows quick deployment at hospitals or other health care facilities for production and distribution of cell and gene therapies on site. Currently, we are deploying our proprietary therapies to POCare centers around the globe including CAR-T therapies targeting blood cancers, Tils targeting solid tumors and reprogrammed cells for regenerative indications. Orgenesis’ Point-of-Care Platform brings automated solutions for mass production of personalized cell and gene therapies making the technology of tomorrow available today and groundbreaking therapies accessible to all.