Form 8-K - Current report

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): July 12, 2024

ORGENESIS INC.

(Exact name of registrant as specified in its charter)

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

20271 Goldenrod Lane, Germantown, MD 20876

(Address of principal executive offices) (Zip Code)

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

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:

☐	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		ORGS		The 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. ☐

Item 1.01 Entry into a Material Definitive Agreement.

On July 12, 2024, Orgenesis Inc. (the “Company”) entered into an Asset Purchase Agreement (the “Purchase Agreement”) with Theracell Advanced Biotechnology S.A, Theracell Advanced Biotechnology LTD and IDNA Genomics Public Limited (collectively, “Theracell”) for the purchase by the Company of the following assets (the “Assets”):

	●	50% of the outstanding ownership rights and equity interests in Theracell Laboratories IKE (“Theracell IKE”) not currently owned by the Company so that the Company shall own 100% of the outstanding equity interests of Theracell IKE; and
	●	Certain products (the “Products”), which include: (i) the manufacturing processes, algorithms, work instructions, test methods, standard operating procedures and specifications for producing Tumor Infiltrating Lymphocytes (“TILs”) that meet current Good Manufacturing Practice (cGMP) requirements that will enable the Company to potentially use this product as a platform for treating a wide variety of solid tumors; (ii) a 3rd generation GMP lentivirus production process, which is part of a therapy manufacturing process that will enable the Company to potentially treat Beta Thalassemia therapies; (iii) an oncolytic virus cell carrier platform which will enable the Company to potentially develop treatments for an array of cancers; (iv) a process for the potential treatment of mesenchymal stem cells for kidney disorders; (v) a process for controlled isolation of regenerative EVs derived from mesenchymal stem cells for the potential treatment of kidney disorders; and (vi) bioxome encapsulated APIs for improved transdermal delivery and bioavailability for the potential treatment of atopic dermatitis/wound healing; including Theracell’s rights, title and interests in and to all intellectual property, including, but not limited to, patents, patent applications, know-how, materials, licenses, permits and approvals relating to Products as further described in the Purchase Agreement.

Pursuant to the Purchase Agreement, in consideration for the purchase of the Assets, the Company will pay Theracell an aggregate purchase price of $13,000,000 (the “Consideration”), which is equal to the value of the Assets established by a third-party valuation firm selected by the Company, less a debt adjustment in the amount of $10,324,241.79 which is owed by Theracell to the Company (the “Debt”). The aggregate Consideration will be paid by the Company as follows: (i) $400,000 will be paid to Theracell within 60 days after signing of the Purchase Agreement, (ii) $250,000 will be paid to Theracell within one year after signing of the Purchase Agreement, and (iii) the remaining amount (less any Debt) will be paid to Theracell in four equal annual payments beginning on December 30, 2025 and ending on December 30, 2028.

The Purchase Agreement contains representations, warranties, and covenants of the parties that are customary for a transaction of this type. The foregoing summary of the Purchase Agreement does not purport to be complete, and is subject to and qualified in its entirety by the Purchase Agreement attached as Exhibit 10.1 to this Current Report on Form 8-K, which is incorporated herein by reference.

Item 2.01 Completion of Acquisition or Disposition of Assets

As described in Item 1.01 of this Current Report on Form 8-K, on July [12], 2024, the Company acquired the Assets pursuant to the Purchase Agreement. The information set forth under Item 1.01 is incorporated into this Item 2.01 by reference.

Item 9.01. Financial Statements and Exhibits.

The exhibit listed in the following Exhibit Index is filed as part of this Current Report on Form 8-K.

Exhibit No.		Description
10.1		Asset Purchase Agreement, dated as of July [12], 2024, among Orgenesis Inc., Theracell Advanced Biotechnology S.A, Theracell Advanced Biotechnology LTD and IDNA Genomics Public Limited*

104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

* Annexes, schedules and/or exhibits have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The Company agrees to furnish supplementally a copy of any omitted attachment to the SEC upon request.

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: July 12, 2024	By:	/s/ Victor Miller
		Victor Miller
		Chief Financial Officer, Treasurer and
		Secretary

Exhibit 10.1

CONFIDENTIAL

ASSET PURCHASE AGREEMENT

for the

Theracell Advanced Biotechnology S.A, Theracell Advanced Biotechnology LTD and ΙDNA Genomics Public Limited (jointly and severally “Theracell”)

and Orgenesis Inc and its subsidiaries. (“Orgenesis”)

July 12^th, 2024

Theracell and Orgenesis intending to be legally bound, hereby agree as follows:

Purchaser	Orgenesis, Inc and / or any of its subsidiaries (“Orgenesis”)

Seller	Theracell Advanced Biotechnology S.A, Theracell Advanced Biotechnology LTD, and ΙDNA GENOMICS PUBLIC LIMITED, jointly and severely (“Seller”).

Assets	Theracell herby sells, assigns and transfers to Orgenesis and Orgenesis hereby purchases from Theracell the following assets (collectively, “Assets”):

	Asset #1

	50% of ownership rights and shares in Theracell Laboratories IKE, so that immediately after such sale, Orgenesis, shall own 100% of the outstanding shares of Theracell Laboratories IKE.

	Asset #2

	The Products described in Exhibit A to this Agreement (“Products”).

Transfer of Rights under JVA	In addition Theracell Advanced Biotechnology LTD hereby transfers and assigns to Orgenesis, free of charge, all of Theracell Advanced Biotechnology LTD’s rights under that certain ATP Joint Venture Agreement entered between Orgenesis and Theracell Advanced Biotechnology LTD, dated December 25, 2022 (“ATP JVA”), including without limitation, all of Theracell Advanced Biotechnology LTD ‘s shares in and/or rights in the JV Entity (as defined in the ATP JVA), and Theracell Advanced Biotechnology, S.A. hereby transfers and assigned to Orgenesis, gratis, all of Theracell Advanced Biotechnology, S.A.’s rights under the Amended and Restated Joint Venture Agreement dated August 21, 2020, between Orgenesis (or its affiliates) and Theracell Advanced Biotechnology, S.A., as revised by the Separation Agreement dated December 22, 2022 (“Amended and Restated JVA”) including without limitation, all of Theracell Advanced Biotechnology SA’s shares in and/or rights in the JV Entity as defined in the Amended and Restated JVA .

Assignment	Each of Theracell, its affiliates, and Mr. Fotis Sakellaridis and Orgenesis shall sign all documents and assignment and take all other actions reasonably requested by Orgenesis to effectuate the transfer and assignment of all rights, title and interest in and to the Assets to Orgenesis. Without limiting the generality of the foregoing, upon the execution of this Agreement, Theracell, its affiliates, and/or Mr. Fotis Sakellaridis (as applicable) shall execute and deliver to Orgenesis the Patent Assignment Agreement attached hereto as Exhibit A.

Consideration	The Parties to this Agreement have commissioned BDO Israel to perform an independent valuation of the Assets being sold pursuant to this agreement. Such valuation, attached hereto as Exhibit E has determined a valuation of US$13,000,000 (Thirteen Million US Dollars). Orgenesis will pay Theracell as consideration for the Assets (“Consideration”) the amount of $13,000,000 (Thirteen Million US Dollars) less any amount due to Orgenesis and/or any of its subsidiaries (the “Debt”). The Consideration will be paid by Orgenesis to Theracell as follows:

		●	The amount of $400,000 (Four Hundred Thousand US Dollars) will be paid to Theracell within 60 (sixty) days after the execution of this Agreement.

		●	The amount of $250,000 (Two Hundred and Fifty Thousand) will be paid to Theracell within one (1) year after the execution of this agreement.

		●	The remaining amount of the Consideration (less any Debt) will be paid in four (4) equal annual payments on 12.30.2025, 12.30.2026, 12.30.2027 and 12.30.2027.

	On any late payment an additional default interest will apply calculated at 10% annually on an actual/365-day conversion.

Waiver and Release/ Representations and Warranties/ Indemnification Clause	Subject to the consummation of the sale, assignment, and transfer of the Assets by Theracell to Orgenesis and fulfillment of all other undertakings as set forth herein, including without limitation Theracell’s indemnification undertaking below, each of Orgenesis and Theracell on behalf of itself, its officers, subsidiaries, affiliated companies, successors and assigns hereby remises, releases and forever discharges and covenants not to sue the other party, its successors, assigns, affiliated companies and all employees, directors, officers and agents thereof, from any liability of any kind, under any law or in tort and under any applicable jurisdiction, whether direct or indirect, foreseen or unforeseen, contingent or actual, present or future, and any claim, cause of action or demand made or to be made by the other party or by any other person on behalf of the other Party, in respect of or arising out of the Assets, MSAs/SOWs, JVAs and/or any other agreement signed between the parties, and any other actions, discussions or negotiations prior to the execution of this Agreement. Notwithstanding the above, Theracell hereby warrants that entering into this Agreement will not result in the imposition of any charge, pledge, attachment, lien, liability, or other burden upon Orgenesis in respect of the Assets transferred and will not give any third parties a cause, right, basis, or claim against Orgenesis and/or its affiliates in respect of the Assets transferred. Without derogating from the foregoing, it is hereby agreed that Orgenesis does not assume any liabilities of Theracell, and that Theracell shall be solely responsible for any charges and liabilities with respect to the Assets and relating to the period prior to the execution of this Agreement, including, without limitation those set forth in listed in Exhibits C and D. Theracell shall indemnify, defend, and hold Orgenesis, its Affiliates and its employees, officers, directors, and agents harmless from and against any and all actions, judgments, settlements, liabilities, damages, penalties, fines, losses, costs, and expenses (including reasonable attorneys’ fees and expenses) to the extent arising out of any third party claim, demand, action and other proceeding (each a “Claim”) related to the Assets transferred.

Confidentiality; Publicity	Each party hereto acknowledges and confirms that this Agreement and all terms hereof are confidential and, subject to applicable law, that neither its existence nor the terms hereof will be disclosed to any other person other than parties’ officers, directors, employees and advisors or potential investors under NDA, unless and to the extent required for fulfillment of any compliance, public company disclosures, legal and/or regulatory obligations.

Disclosure Exhibits	Exhibit C and Exhibit D for disclosure purposes are attached hereto.

Governing Law	This Agreement shall be governed by the laws of the State of New York, United States of America, without regard to its conflict of law provisions.

Binding Agreement; Further Assurances	Each Party represents and warrants to the other Party that this Agreement is a legal and valid obligation binding upon such Party and is enforceable in accordance with its terms. This Agreement supersedes any prior agreements between the parties with respect to the subject matter hereof. The execution, delivery, and performance of this Agreement by such party does not conflict with any agreement, instrument or understanding, oral or written, to which such Party is a party or by which such party may be bound, nor violate any law or regulation of any court, governmental body or administrative or other agency having authority over such party. From time to time, at Orgenesis’ request and without further consideration, Theracell shall execute and deliver such additional documents and take all such further action as may be reasonably necessary or reasonably requested to effect the actions and consummate the transactions contemplated by this Agreement.

	IN WITNESS WHEREOF, the parties have executed this Agreement as of the dates set forth below.

Theracell Advanced Biotechnology, S.A			Orgenesis Inc.

by:			by:
name:			name:
title:			title:

Theracell Advanced Biotechnology LTD

by:
name:
title:

IDNA GENOMICS PUBLIC LIMITED

by:
name:
title:

Agreed and accepted by Mr. Fotis Sakellaridis:______________

Cover	Jul. 12, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Jul. 12, 2024
Entity File Number	001-38416
Entity Registrant Name	ORGENESIS INC.
Entity Central Index Key	0001460602
Entity Tax Identification Number	98-0583166
Entity Incorporation, State or Country Code	NV
Entity Address, Address Line One	20271 Goldenrod Lane
Entity Address, City or Town	Germantown
Entity Address, State or Province	MD
Entity Address, Postal Zip Code	20876
City Area Code	(480)
Local Phone Number	659-6404
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock
Trading Symbol	ORGS
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false