irbio-8k6909.htm
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): June 4,
2009
IR
BIOSCIENCES HOLDINGS, INC.
(Exact
name of registrant specified in charter)
|
Delaware
|
033-05384
|
13-3301899
|
|
(State
of Incorporation)
|
(Commission
File Number)
|
(IRS
Employer Identification
No.)
|
8777
E. Via De Ventura, Suite 280
Scottsdale, AZ 85258
(Address
of principal executive offices) (Zip Code)
(480)
922-3926
(Registrant’s
telephone number, including area code)
N/A
(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):
o Written communications
pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material
pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
o Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
o Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
On June
4, 2009, IR BioSciences Holdings, Inc. (the “Company”), a Delaware corporation,
received acknowledgement from YA Global Investments, L.P. (“YA Global”) that YA
Global has reviewed and accepted the Company’s recent submission of an
Investigational New Drug Application (IND) to the U.S. Food and Drug
Administration (FDA). This submission makes for successful completion
by the Company of the third, and final, milestone obligation under provisions of
the convertible debentures issued by the Company to YA Global. As per the term
of the convertible debentures, successful completion of the final milestone is
defined as submission of an IND for the use of Homspera in humans which IND was
required to be submitted to the FDA for at least one clinical trial (Phase I) in
humans by June 30, 2009.
On May
28, 2009, ImmuneRegen BioSciences, Inc., a wholly owned subsidiary of IR
BioSciences Holdings, Inc. submitted the IND to the FDA to begin human clinical
testing of Homspera, an analog of the endogenous neurokinin Substance P, as a
treatment for Idiopathic Pulmonary Fibrosis, a condition for which there are no
consistently effective drugs approved for human use in the U.S.
The
convertible debentures were sold pursuant to a securities purchase agreement
dated as of January 3, 2008 (the “Agreement”) providing for the issuance of (i)
convertible debentures in an aggregate principal amount up to $3,000,000
(collectively, the “Convertible Debentures”) which are convertible into shares
(the “Conversion Shares”) of the Company’s common stock, par value $.001 per
share (the “Common Stock”), and (ii) warrants (the “Warrants”) to purchase
7,500,000 shares of Common Stock (the “Warrant Shares”). The initial closing of
the Agreement occurred on January 3, 2008, at which time the Company sold to YA
Global $2 million of the Debentures and the Warrants, and on June 12, 2008 the
Company exercised its option to sell and issue to YA Global an additional $1
million of the Debentures.
This
summary is qualified in its entirety by reference to the full text of the
Convertible Debenture attached as Exhibit 4.1, the Common Stock Purchase Warrant
attached as Exhibit 4.2, the Agreement attached as Exhibit 10.1, the Guaranty
Agreement attached as Exhibit 10.2, the Security Agreement attached as Exhibit
10.3 and the Patent Security Agreement attached as Exhibit 10.4, all to the
report on Form 8-K filed on January 9, 2008 and all of which is incorporated
herein by this reference.
The
information in this Report on Form 8-K is furnished pursuant to Item 7.01 and
shall not be deemed to be "filed" for the purpose of Section 18 of the
Securities Exchange Act of 1934 or otherwise subject to the liabilities of that
section. This Report will not be deemed an admission as to the materiality of
any information in the Report that is required to be disclosed solely by
Regulation FD.
The
Company does not have, and expressly disclaims, any obligation to release
publicly any updates or any changes in the Company's expectations or any change
in events, conditions, or circumstances on which any forward-looking statement
is based.
THIS
CURRENT REPORT IS NOT AN OFFER OF SECURITIES FOR SALE. ANY SECURITIES
SOLD IN AS DESCRIBED ABOVE HAS NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF
1933, AS AMENDED, AND MAY NOT BE OFFERED OR SOLD IN THE UNITED STATES UNLESS
REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, OR PURSUANT TO AN
EXEMPTION FROM SUCH REGISTRATION.
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.
|
|
|
|
|
|
IR
BIOSCIENCES HOLDINGS, INC.
|
|
|
|
|
|
Dated:
June 9, 2009
|
By:
|
/s/ Michael K
Wilhelm
|
|
|
Michael
K Wilhelm
|
|
|
President
and CEO
|