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) March 16, 2015
ORGENESIS INC.
(Exact name of registrant as specified in its charter)
Nevada | 000-54329 | 980583166 |
(State or other jurisdiction | (Commission | (IRS Employer |
of incorporation) | File Number) | Identification No.) |
20271 Goldenrod Lane, Germantown, MD
20876
(Address of principal executive offices) (Zip Code)
Registrants 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))
2
Item 1.01 Entry into a Material Definitive Agreement
On March 16, 2015 we executed a consulting agreement with Professor Itamar Raz. Prof. Raz has agreed to be appointed to our Board of Advisors committee, in consideration for an hourly fee for attending in person meetings and meetings via conference call. We will also grant Prof. Raz 100,000 stock options exercisable at current market prices. The options will be subject to our stock option plan and will have vesting provisions. Prof. Raz will also be reimbursed for out of pocket expenses incurred for carrying out consulting business.
We granted the securities to one non-U.S. person (as that term is defined in Regulation S of the United States Securities Act of 1933 , as amended) in an offshore transaction in which we relied on the registration exemption provided for in Regulation S and/or Section 4(2) of the Securities Act of 1933 .
The agreement is for an indefinite period unless terminated by either party with 30 days advance written notice to the other party.
A copy of the agreement is attached as exhibit 10.1 to this current report on Form 8-K.
Item 3.02 Unregistered Sales of Equity Securities.
The disclosure under Item 1.01 of this current report on Form 8-K is responsive to this Item and is hereby incorporated by reference.
Item 9.01. | Financial Statements and Exhibits. |
10.1 | Orgenesis Inc. Board of Advisors Consulting Agreement dated March 16, 2015 |
99.1 | News release dated March 16, 2015 |
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.
By:
/s/ Neil Reithinger |
Neil Reithinger |
Chief Financial Officer, Treasurer and Secretary |
March 17, 2015 |
For Immediate Release
Orgenesis Appoints Itamar Raz as Newest Member of Board of Advisors
GERMANTOWN, MDMar. 16, 2015 Orgenesis Inc . (OTCQB: ORGS) a development-stage company with a novel therapeutic technology dedicated to converting a patient's own liver cells into functioning insulin-producing cells as a treatment for diabetes, today announced that Professor Itamar Raz has been appointed to the Orgenesis board of advisors.
Prof. Raz has been involved in a number of organizations focused on diabetes, as well as in other medical associations. In 2004, he became the head of the Israel National Diabetes Council. At this time he also became President of the nonprofit organization, D-Cure (Diabetes Care to Cure in Israel). Prof. Raz is well known as both an academic and clinician, having served as Chief Physician at Hebrew University and Director of the Hadassah Center for the Prevention of Diabetes and its Complications at Hadassah University Hospital.
Itamar Raz is a choice addition to our board of advisors at Orgenesis, said Vered Caplan, Chairperson and CEO of Orgenesis. He has spent time in academic medicine, which has given way to a thorough knowledge in the medical field and in hospitals. His experience on both national and international associations, particularly those centering on diabetes, will make his transition to the board seamless. He will be an incredible asset in our quest to solve diabetes with regenerative medicine.
Professor Itamar Raz is a preeminent authority in the diabetes world, said Dr. Alexander Fleming, Orgenesis advisory board member and former head of diabetes drug review at the FDA. He brings great experience in clinical trials and therapeutic development across the spectrum of drugs, biologics, and devices in type 1 and type 2 diabetes. He is a highly respected scientist and clinician across the globe for his many contributions and insights. I am thrilled that Prof. Raz has decided to join us.
Prof. Raz served from 1966 to 1969 as a Captain in the Military; he was also involved in Infantry and the Medical Corps. He studied Pharmacology at Hebrew University, and received his B.S. at the Hadassah School of Pharmacy in Jerusalem. He then obtained his M.D. in medicine and internal medicine in his following studies, which took place at the Hadassah University Hospital.
Currently, Itamar Raz is a Professor of Medicine and Head of the Diabetes Unit at the Hadassah Ein Kerem Hospital in Jerusalem.
About Orgenesis, Inc.
Orgenesis is a development
stage company that is committed to curing Type 1 Diabetes. In pursuit of this
goal, the Company is developing a novel technology that combines cellular
therapy and regenerative medicine. Through a proprietary biologic process called
cellular trans-differentiation, Orgenesis has proven that, when exposed ex
vivo to certain pancreatic transcription factors and in specific sequence, human
adult liver cells can be transformed into fully functional, beta cell-like
insulin producing cells (IPCs). After ex vivo expansion, the IPCs are re-infused
via the portal vein. In pre-clinical models of Type 1 Diabetes (Non-Obese
Diabetic mice), the re-introduced IPCs remain in the liver, effectively respond
to glucose challenge and successfully maintain glycemic homeostasis. In the same
NOD model, the implanted IPCs were not subject to auto-immune attack or cellular
ablation. Orgenesis plans to initiate P1/2 trials in the next 12-16 months. For
more information visit:
www.orgenesis.com
.
Notice Regarding Forward-Looking Statements
This
news release contains "forward-looking statements" which are not purely
historical. Such forward-looking statements include, among other things, the
expectations of management that our regeneration technology can be developed as
therapeutic treatment for diabetes which could, if successful, mean the end of
diabetes as we know it; that we will initiate Phase I and Phase II clinical
trials in the United States in the near-term; that we can quickly transition our
technology from research into P1 clinical trials. No assurance can be given that
any of the events anticipated by the forward-looking statements will occur or,
if they do occur, what benefits Orgenesis will obtain from them. Actual results
could differ from those projected in any forward-looking statements due to
numerous factors, including, among others, the potential failure of development
candidates to advance through preclinical studies or demonstrate safety and
efficacy in clinical testing; the ability to pass clinical trials so as to move
on to the next phase; our ability to retain key employees; our ability to
finance development and operations; our ability to satisfy the rigorous
regulatory requirements for new medical procedures; and competitors may develop
better or cheaper alternatives to our products. These forward-looking statements
are made as of the date of this news release, and we assume no obligation to
update the forward-looking statements, or to update the reasons why actual
results could differ from those projected in the forward-looking statements.
Investors should refer to the risk factors disclosure outlined in our periodic
reports filed from time-to-time with the Securities and Exchange Commission.
Company Contact: |
Scott P. Carmer |
Orgenesis |
301-204-1983 |
scott.c@orgenesis.com |
Media Contact: |
Tim Rush |
Springboard5 |
(801) 208-1100 |
tim.rush@springboard5.com |