Unassociated Document
Filed
Pursuant to Rule 424(b)(3)
Registration
No. 333-136904
Prospectus
Supplement No. 9
(to
Prospectus dated April 25, 2007)
CLEVELAND
BIOLABS, INC.
4,453,601
Shares
This
Prospectus Supplement No. 9 supplements and amends the prospectus dated April
25, 2007 (the “Prospectus”) relating to the offer and sale of up to 4,453,601
shares of our common stock which may be offered from time to time by the
selling
stockholders identified in the Prospectus for their own accounts. This
Prospectus Supplement is not complete without, and may not be delivered or
used
except in connection with the original Prospectus.
This
Prospectus Supplement No. 9 includes the attached Form 8-K of Cleveland BioLabs,
Inc. dated April 3, 2008, as filed by us with the Securities and Exchange
Commission.
This
Prospectus Supplement No. 9 modifies and supersedes, in part, the information
in
the Prospectus. Any information that is modified or superseded in the Prospectus
shall not be deemed to constitute a part of the Prospectus, except as modified
or superseded by this Prospectus Supplement No. 9. We may amend or supplement
the Prospectus from time to time by filing amendments or supplements as
required. You should read the entire Prospectus and any amendments or
supplements carefully before you make an investment decision.
Investing
in our common stock involves risk. See “Risk Factors” beginning on page 8 of the
Prospectus.
Neither
the Securities and Exchange Commission nor any state securities commission
has
approved or disapproved of these securities or determined if the Prospectus
or
this Prospectus Supplement No. 9 is truthful or complete. Any representation
to
the contrary is a criminal offense.
The
date
of this Prospectus Supplement No. 9 is April 3, 2008.
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): April 3, 2008
CLEVELAND
BIOLABS, INC.
(Exact
name of registrant as specified in its charter)
|
|
|
|
|
Delaware
|
|
001-32954
|
|
20-0077155
|
(State
or other jurisdiction
of
incorporation or organization)
|
|
(Commission
File Number)
|
|
(I.R.S.
Employer
Identification
Number)
|
73
High Street, Buffalo, New York 14203
(Address
of principal executive offices)
Registrant’s
telephone number, including area code: (716) 849-6810
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))
|
On
April
3, 2008, Cleveland BioLabs, Inc. (the “Company”) issued a press release
announcing that it has been awarded a contract by the U.S. Department of
Defense
for up to approximately $8.9 million to fund the advanced development of
the
Company’s lead product candidate, Protectan CBLB502, as a medical radiation
countermeasure. A copy of the press release is attached as Exhibit
99.1.
Item 9.01
|
Financial
Statements and Exhibits
|
(d)
Exhibits
Exhibit
No.
|
|
Exhibit
|
|
|
|
99.1
|
|
Press
Release dated April 3, 2008.
|
SIGNATURE
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.
|
|
|
|
CLEVELAND
BIOLABS,
INC |
|
|
|
Date: April
3, 2008 |
By: |
/s/
Michael
Fonstein |
|
Michael
Fonstein
President
and Chief Executive Officer
|
|
|
EXHIBIT
INDEX
Exhibit
No.
|
|
Exhibit
|
|
|
|
99.1
|
|
Press
Release dated April 3, 2008.
|
FOR
IMMEDIATE RELEASE
DEPARTMENT
OF DEFENSE AWARDS CLEVELAND BIOLABS CONTRACT
TO
DEVELOP PROTECTAN CBLB502
Buffalo,
NY — April 3, 2008 - Cleveland BioLabs, Inc. (NASDAQ:CBLI) today
announced that the Department of Defense (DoD) has awarded the Company a
letter
contract through the Chemical Biological Medical Systems (CBMS) Joint Project
Management Office Broad Agency Announcement
(http://www.jpeocbd.osd.mil/page_manager.asp?pg=2&sub=66) for selected tasks
in the advanced development of Protectan CBLB502 as a Medical Radiation
Countermeasure to treat radiation injury following exposure to radiation
from
nuclear or radiological weapons. A letter contract is a written preliminary
contractual instrument that authorizes initial performance prior to negotiating
a definitized contract.
When definitized, this contract shall not exceed $8.9 million in development
funding.
Michael
Fonstein, Ph.D., Chief Executive Officer and President of Cleveland BioLabs
stated, “The DoD's funding of Protectan CBLB502 reflects their evaluation of its
potential safety and efficacy as a medical radiation countermeasure and
recognition of its potential suitability for the armed forces’ needs
on
the battlefield. We are pleased to be working for CBMS, which rapidly provides
the Warfighter with safe, robust, affordable medical countermeasures against
the
broad spectrum of CBRN threats. We hope that Protectan CBLB502, when approved
by
the FDA, will offer a practical solution for one of the deadliest threats
that
exists in today's world.”
“We
have
collaborated closely with the Armed Forces Radiobiology Research Institute
on
development of Protectan CBLB502 for several years and believe its unique
abilities to mitigate both hematopoietic and gastrointestinal effects of
ionizing radiation as well as demonstrate significant survival benefits are
well
suited to the DoD’s requirements,” continued Dr. Fonstein. “Moreover, we believe
the compound’s safety profile, stability, method of administration and cost
effectiveness, make it highly practical for field deployment. We believe
Protectan CBLB502, with its potential to protect both military and civilian
populations, will play a significant role in domestic and global biodefense
preparedness.”
Colonel
David Williams, Joint Project Manager, CBMS, commented: “CBMS uses Government
and commercial best practices to acquire FDA-approved CBRN medical
countermeasures and diagnostics. CBMS protects the Warfighter by maintaining
uncontested global supremacy in CBRN medical countermeasure development and
delivery. CBMS is pleased to contribute to Cleveland BioLabs’ advanced
development of Protectan CBLB502, which is a promising drug candidate for
the
Joint requirements of the DoD. Preliminary data suggests that Protectan CBLB502
is safe and efficacious in animals, is suitable for use on the battlefield
or
following evacuation, and has a manageable logistics burden.”
Protectan
CBLB502 is a bio-engineered derivative of a microbial protein that reduces
injury from acute stresses by mobilizing several natural cell protecting
mechanisms, including inhibition of programmed cell death (apoptosis), reduction
of oxidative damage and induction of regeneration promoting cytokines. Cleveland
BioLabs plans to initiate a Phase I human safety trial in the first half
of 2008
for Protectan CBLB502 in Acute Radiation Syndrome. Subsequently, Phase II
expanded clinical safety trials and definitive animal efficacy studies are
planned in support of FDA approval using the “Animal Rule.” The FDA’s “Animal
Rule” provides an alternate path for the approval or licensure of drugs and
biologics, which cannot ethically be tested definitively for efficacy in
human
volunteers.
About
Cleveland BioLabs, Inc.
Cleveland
BioLabs, Inc. is a drug discovery and development company leveraging its
proprietary discoveries about programmed cell death to treat cancer and protect
normal tissues from exposure to radiation and other stresses. The Company
has
strategic partnerships with the Cleveland Clinic, Roswell Park Cancer Institute,
ChemBridge Corporation and the Armed Forces Radiobiology Research Institute.
To
learn more about Cleveland BioLabs, Inc., please visit the company's website
at
http://www.cbiolabs.com.
This
press release contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. Forward-looking statements
reflect management’s current expectations, as of the date of this press release,
and involve certain risks and uncertainties. The Company’s actual results could
differ materially from those anticipated in these forward-looking statements
as
a result of various factors. Some of the factors that could cause future
results
to materially differ from the recent results or those projected in
forward-looking statements include the "Risk Factors" described in the Company’s
periodic filings with the Securities and Exchange Commission.
Company
Contact:
Rachel
Levine, Director Corporate Development & Communications
Cleveland
BioLabs, Inc.
T:
(646)
284-9439
E:
rlevine@cbiolabs.com
Media
Contact
Ivette
Almeida
Global
Consulting Group
T:
(201)
232-0128
E:
ialmeida@hfgcg.com