Statera Biopharma and Lay Sciences Inc. Announce Intent to Enter Strategic Partnership to License the Manufacturing Rights to Certain Lay Sciences IgY Products
2022年5月13日 - 8:30PM
Statera Biopharma (Nasdaq: STAB) (the “Company”), a
biopharmaceutical company creating next-generation immune therapies
that focus on immune restoration and homeostasis, announced today
that the Company intends to enter into a non-binding term sheet
with respect to a strategic partnership with Lay Sciences, Inc.
(“Lay Sciences”), a development and commercialization company of
innovative solutions, to license worldwide manufacturing rights to
certain Lay Sciences’ IgY products containing avian antibodies as
an active ingredient.
“The strategic partnership with Lay Sciences has
the potential to produce near term revenue,” said Michael K.
Handley, President and Chief Executive Officer of Statera
Biopharma. “The agreement allows Statera the right to supply the
products for the existing approved markets. Statera also receives
the right to license and commercialize current and future products
for other indications.”
Under the terms of the proposed agreement, Lay
Sciences would receive an upfront payment comprised of both equity
and cash and would also have the potential to earn royalties and
milestones associated with the development of IgY in
gastrointestinal and upper respiratory indications.
“Lay Sciences is pioneering a new generation of
treatment and prophylaxis with proprietary formulations that
protect IgY from gastric acids and proteases that allows for
release of antibodies to targeted regions of the gut,” said Satish
Chandran, Chief Executive Officer, Lay Sciences, Inc. “We are
excited to partner with Statera and believe oral polyclonal IgY
antibodies allow for therapeutic intervention and for prophylaxis
in a targeted manner that will enhance our ability to combat
chronic, life‐threatening diseases.”
About Statera Biopharma
Statera Biopharma (formerly Cytocom, Inc.) is a
clinical-stage biopharmaceutical company developing novel
immunotherapies targeting autoimmune, neutropenia/anemia, emerging
viruses and cancers based on a proprietary platform designed to
rebalance the body’s immune system and restore homeostasis. Statera
has one of the largest platforms of toll-like receptor (TLR)
agonists in the biopharmaceutical industry with TLR4
and TLR9 antagonists, and the TLR5 agonists, Entolimod
and GP532. TLRs are a class of protein that plays a key role
in the innate immune system. Statera is developing therapies
designed to directly elicit within patients a robust and durable
response of antigen-specific killer T-cells and antibodies, thereby
activating essential immune defenses against autoimmune,
inflammatory, infectious diseases, and cancers. Statera has
clinical programs for Crohn’s disease
(STAT-201), hematology (Entolimod), pancreatic cancer
(STAT-401) and COVID-19 (STAT-205) in addition to potential
expansion into fibromyalgia and multiple sclerosis. To learn
more about Statera Biopharma, please visit
www.staterabiopharma.com.
About Lay Sciences, Inc.
Lay Sciences is a global leader in the
development and commercialization of innovative, high value-added
solutions to advance clinical performance, define standard of care
and improve patient outcomes. Using patent pending and proprietary
technologies owned by Lay Sciences or licensed from its partnering
companies, ReaGene Biosciences Pvt. Ltd., Prodigy Biotech, Inc. and
Kyntox Biotech India Pvt. Ltd., Lay Sciences is dedicated to
developing and providing innovative products and devices focused on
treating and preventing diseases of the GI tract. The company’s
flagship product, ImmunIgY™, is the first-in-class
antibody-based oral product developed to address the pivotal step
in viral entry and infection. For more information, please
visit www.myimmunigy.com or www.laysciences.com
Forward Looking Statements
This press release contains forward-looking
statements that involve risks and uncertainties. All statements
other than statements of current or historical fact contained in
this press release, including statements regarding the Company’s
expected clinical development timeline for the Company’s product
candidates, future financial position, business strategy, new
products, budgets, liquidity, cash flows, projected costs,
regulatory approvals, the impact of any laws or regulations
applicable to the company, and plans and objectives of management
for future operations, are forward-looking statements. The words
“anticipate,” “believe,” “continue,” “should,” “estimate,”
“expect,” “intend,” “may,” “plan,” “project,” “will,” and similar
expressions, as they relate to us, are intended to identify
forward-looking statements. We have based these forward-looking
statements on the current expectations about future events held by
management. While we believe these expectations are reasonable,
such forward-looking statements are inherently subject to risks and
uncertainties, many of which are beyond the Company’s control. The
company’s actual future results may differ materially from those
discussed here for various reasons. The Company discusses many of
these risks under the heading “Risk Factors” in the proxy
statement/prospectus filed with the SEC on June 10, 2021, as
updated by the company’s other filings with the SEC. Factors that
may cause such differences include, but are not limited to, the
outcome of any legal proceedings that have been or may be
instituted against the company related to the merger between
Cleveland BioLabs and Cytocom; unexpected costs, charges or
expenses resulting from the merger; the Company’s need for
additional financing to meet the Company’s business objectives; the
Company’s history of operating losses; the Company’s ability to
successfully develop, obtain regulatory approval for, and
commercialize the Company’s products in a timely manner; the
Company’s plans to research, develop and commercialize the
Company’s product candidates; the Company’s ability to attract
collaborators with development, regulatory and commercialization
expertise; the Company’s plans and expectations with respect to
future clinical trials and commercial scale-up activities; the
Company’s reliance on third-party manufacturers of the Company’s
product candidates; the size and growth potential of the markets
for the Company’s product candidates, and the Company’s ability to
serve those markets; the rate and degree of market acceptance of
the Company’s product candidates; regulatory requirements and
developments in the United States, the European Union and foreign
countries; the performance of the Company’s third-party suppliers
and manufacturers; the success of competing therapies that are or
may become available; the Company’s ability to attract and retain
key scientific or management personnel; the Company’s historical
reliance on government funding for a significant portion of the
Company’s operating costs and expenses; government contracting
processes and requirements; the exercise of significant influence
over the Company’s company by the Company’s largest individual
stockholder; the impact of the novel coronavirus (“COVID-19”)
pandemic on the Company’s business, operations and clinical
development; the geopolitical relationship between the United
States and the Russian Federation as well as general business,
legal, financial and other conditions within the Russian
Federation; the Company’s ability to obtain and maintain
intellectual property protection for the Company’s product
candidates; the Company’s potential vulnerability to cybersecurity
breaches; and other factors discussed in the Company’s SEC filings,
including the Company’s Annual Report on Form 10-K for the year
ended December 31, 2020 and the risk factors discussed under the
heading “Risk Factors” in the proxy statement/prospectus the
company filed in connection with the merger on June 10, 2021.
Given these uncertainties, you should not place
undue reliance on these forward-looking statements. The
forward-looking statements included in this press release are made
only as of the date hereof. We do not undertake any obligation to
update any such statements or to publicly announce the results of
any revisions to any of such statements to reflect future events or
developments.
Contacts:
Statera BiopharmaNichol OchsnerExecutive V.P.
Investor Relations and Corporate
Communications+1.732.754.2545nichol.ochsner@staterabiopharma.com
FINN PartnersGlenn
Silver+1.973.818.8198glenn.silver@finnpartners.com
FINN PartnersDavid Carey (IR)+1.212.
867.1768David.carey@finnpartners.com
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