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 20, 2006
CLEVELAND
BIOLABS, INC.
(Exact
name of registrant as specified in its charter)
|
|
|
|
|
Delaware
|
|
001-12465
|
|
20-0077155
|
(State
or other jurisdiction
of
incorporation or organization)
|
|
(Commission
File Number)
|
|
(I.R.S.
Employer
Identification
Number)
|
|
|
|
|
|
|
|
11000 Cedar Ave.,
Suite
290
|
|
|
|
|
(Address of principal
executive offices)
|
|
|
Registrant’s
telephone number, including area code: (216) 229-2251
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))
|
Item 1.01.
|
Entry
into a Material Definitive
Agreement
|
On
October 20, 2006, Cleveland BioLabs, Inc. (the “Company”) finalized an agreement
with SynCoBio Partners B.V. to manufacture quantities of one of the Company’s
lead product candidates, Protectan CBLB502, for clinical trials and, if approved
by governmental authorities, for commercial distribution. A copy of the
agreement is attached as Exhibit 10.01 and incorporated herein by
reference.
On
October 25, 2006, the Company sent to its stockholders a letter summarizing
various developments regarding the Company and its business. A copy of the
letter is attached as Exhibit 99.1 and incorporated herein by reference.
Item
9.01 Financial Statements and Exhibits
(c)
Exhibits
Exhibit
No.
|
|
Exhibit
|
|
|
|
10.01
|
|
Process
Development and Manufacturing Agreement between Cleveland BioLabs,
Inc.
and SynCoBio Partners B.V. effective as of August 31,
2006.
|
|
|
|
99.1
|
|
Letter
to Stockholders from Michael Fonstein, President and Chief Executive
Officer dated October 25, 2006
|
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: October
25, 2006
|
By:
|
/s/ Michael
Fonstein
|
|
Michael
Fonstein
|
|
President
and Chief Executive Officer
|
EXHIBIT
INDEX
Exhibit
No.
|
|
Exhibit
|
|
|
|
10.01
|
|
Process
Development and Manufacturing Agreement between Cleveland BioLabs,
Inc.
and SynCoBio Partners B.V. effective as of August 31,
2006.
|
|
|
|
99.1
|
|
Letter
to Stockholders from Michael Fonstein, President and Chief Executive
Officer dated October 25, 2006
|
Dear
Stockholder,
It
has
been just three months since Cleveland BioLabs Inc. (Nasdaq:CBLI) has become
public and we are making great strides in our research and development. There
have been several significant positive events recently and others are expected
in the near future. We are encouraged by the recent appreciation in the price
of
our stock. We have undertaken an aggressive market communications strategy
and
retained investor relations consultants to help implement this
strategy.
Over
the
last few months, CBLI achieved a number of important milestones:
|
·
|
We
received FDA approval to start a Phase II trial of our Curaxin CBLC102
compound for advanced, refractory prostate
cancer;
|
|
·
|
We
reported highly successful preliminary results for our non-human
primate
efficacy trial of Protectan CBLB502 for radiation protection (injected
prior to exposure);
|
|
·
|
We
received two Phase II awards from NIH totaling $1,500,000 (and fundable
scores for three more) bringing the total number of grants and contracts
we received from NIH, DOD and NASA to 13;
and
|
|
·
|
We
very recently achieved a breakthrough in our radiation protection
program,
demonstrating CBLB502’s efficacy in mice after exposure to radiation and
potentially expanding the market potential for this
compound.
|
Cleveland
BioLabs’ mission is to develop drugs that treat cancer and protect us from
radiation and other deadly diseases acting through similar molecular mechanisms.
This development is based on our original research in the area of apoptosis
(programmed cell death) and the discovery of a unique source of molecules
modulating this process.
Apoptosis
is a basic cellular defense mechanism that responds to DNA damage and various
other stresses and determines whether a damaged cell should be repaired or
killed. Through this mechanism, apoptosis prevents improperly repaired or
damaged cells from becoming cancerous, which means that cancerous cells need
to
block this mechanism in order to successfully develop. If we unblock this
mechanism in a mature cancer cell, it will recognize the cancer signals and
kill
the cell. Conversely, external stresses, like radiation, induce apoptosis and
at
high doses kill too many potentially repairable cells, causing damage in
critical tissues and death of an organism. In this case, delaying the apoptotic
response and enabling cells to recover can drastically reduce the negative
impact of radiation on the organism.
CBLI’s
drugs act on both sides of this equation. Curaxins turn apoptosis on to kill
cancer cells, and Protectans temporarily turn apoptosis off to protect against
cell death as a result of radiation or other stresses.
Our
lead
Curaxin, CBLC102, is an oral drug that works in vitro, in animal models, and
in
live tumors removed from patients. The
FDA
has approved a Phase II efficacy study
at the
Cleveland Clinic and Case Western Reserve University Hospital and enrollment
will start shortly for advanced, refractory prostate cancer. Independent
research has shown that the majority of cancers can be targeted by our drug
candidate based on this mechanism of suppression of apoptosis.
Our
lead
Protectan, CBLB502, shows unprecedented protection against radiation when
injected into mice prior to exposure. This has resulted in the survival of
the
animals after exposure to super-killing doses of up to 14 Gy of total body
irradiation. CBLB502 can prevent both hematopoietic (HP) and gastro-intestinal
(GI) acute radiation syndromes and is the first known substance that protects
against the lethal GI syndrome.
Very
recently, we achieved a significant breakthrough in our radiation protection
program. We demonstrated that CBLB502 is effective even when injected after
mice
have been exposed to radiation doses up to 9Gy. This could significantly expand
the drug’s market potential, adding the ability to use it for the general
population following radiation exposure.
Experiments
with cancer-bearing mice have also established the potential for Protectan
CBLB502 to be used as an adjuvant to radiation therapy for cancer treatment.
Its
use allows an increase in tolerable doses of radiation, with no protective
effect on tumors, thus strengthening the therapeutic effect of the
treatment.
CBLB502
also showed strong radioprotection in non-human primates, enabling the survival
of over 70% of animals that received deadly doses of whole-body radiation.
This
drug is undergoing an
accelerated
development program under the FDA two-animal rule
,
which
requires us to show efficacy in two animal species (including primates) and
only
safety in humans.
Based
on
the efficacy demonstrated in primates and our progress in developing GMP
manufacturing with SynCo Bio Partners B.V., we believe that we may be able
to
submit
an
NDA to the FDA within approximately 24 months
.
In
addition, there is a possibility that we could receive orders from the
Department of Defense in an even shorter timeframe. CBLB502 is initially being
developed as a radiation antidote for the military, first responders, nuclear
plant workers and eventually for all people who will be subject to nuclear
attack or accident.
We
are
very excited about all of these advances and continue to leverage our strategic
relationships with the Cleveland Clinic Foundation, ChemBridge Corporation
and
the Armed Forces Research Radiobiology Institute to further our development.
Our
partnership with the Cleveland Clinic has given us access to state of the art
facilities and world-accomplished researchers to help develop our compounds.
In
fact, the company has the exclusive right to all intellectual property developed
by two major labs at the Cleveland Clinic in the area of cancer and tissue
protection. In addition, ChemBridge has provided a library of more than 250,000
chemical compounds which tremendously strengthens our research efforts. The
Armed Forces Research Radiobiology Institute has been critical in advancing
our
research and development efforts with Protectans.
In
summary, we believe CBLI will be successful because of the following
factors:
•
Proprietary technology platform supported by 14 patent applications;
•
Late-stage products with accelerated development pathways;
•
Extensive pipeline supported by 13 government grants and contracts;
and
•
Near-term value drivers.
We
remain
committed to delivering shareholder value and appreciate your
support.
Sincerely,
Michael
Fonstein
Chief
Executive Officer
Cleveland
BioLabs, Inc.
This
letter contains forward-looking statements that reflect our current view with
respect to various aspects of the events described above. Statements that use
terms like “expect,” “could,” “believe,” and other similar expressions are
intended to identify forward-looking statements. Actual results could be
significantly different. Factors that could affect results those set forth
in
filings made by Cleveland BioLabs, Inc. with the Securities and Exchange
Commission. These factors include, but are not limited to, those discussed
in
our Registration Statement on Form SB-2 under the caption “Risk Factors” We
caution you not to place undue reliance on these forward-looking statements.
Although forward-looking statements help provide complete information about
future prospects, you should keep in mind that forward-looking statements are
much less reliable than historical information.