CohBar, Inc. (NASDAQ: CWBR) (“CohBar” or the “company”) and
Morphogenesis, Inc. (“Morphogenesis”), a privately-held Phase 2/3
clinical-stage biotechnology company developing novel personalized
cancer vaccines and tumor microenvironment modulators to overcome
resistance to current immunotherapies, today announced that they
have entered into a definitive agreement for an all-stock
transaction forming a company combining expertise and resources to
advance a late-stage oncology pipeline. The combined company will
focus on advancing Morphogenesis’ two technologies that seek to
overcome the major obstacles that limit the effectiveness of
current immunotherapies in treating cancer. The combined company is
expected to operate under the name “TuHURA Biosciences, Inc.” and
to trade on The Nasdaq Capital Market (“Nasdaq”). The transaction
is expected to close in the third quarter of 2023.
“Following a thorough review and evaluation, we
believe merging with Morphogenesis and leveraging their late-stage
pipeline of novel immuno-oncology technologies represents the best
path forward for our stockholders and has the potential to deliver
near and long-term value,” stated Dr. Joseph Sarret, CEO of CohBar.
“Our board and management team believe that the combined company
will be well-positioned to develop powerful new therapies with the
potential to overcome resistance to current immunotherapies, an
area of significant unmet need.”
Morphogenesis’ technologies, which can be used
to target large unmet medical needs across a variety of cancers,
include:
- Immune Fx (IFx) Personalized Cancer Vaccines:
IFx is designed to prime and activate an innate immune response
against patient-specific tumor antigens, overcoming primary
resistance to checkpoint inhibitors. Morphogenesis is currently
preparing for a single Phase 2/3 registration trial of its lead
personalized cancer vaccine, IFx-Hu2.0, as an adjunct to Keytruda®
(pembrolizumab) in first line treatment for advanced Merkel Cell
Carcinoma (MCC). This study is expected to be conducted under a
Special Protocol Assessment (SPA) agreement with the FDA and to
commence in early 2024. Additionally, Morphogenesis is advancing
IFx-Hu3.0, its mRNA vaccine, toward IND-enabling studies in 2024
for the treatment of aggressive diffuse large B-cell lymphoma
(DLBCLs).
- Tumor Microenvironment (TME) Modulators: TME
Modulators are designed to address one of the primary causes of
acquired resistance to immunotherapies, including checkpoint
inhibitors or cellular therapies like CAR-T. Leveraging its new
class of novel bi-functional antibody drug conjugates (ADCs),
Morphogenesis is targeting a recently identified delta receptor on
myeloid derived suppressor cells (MDSCs). MDSCs comprise a major
component of cells in the tumor microenvironment and are
responsible for suppressing the immune system’s attack against the
tumor. Morphogenesis is constructing several MDSC targeted,
bi-functional ADCs for in vitro and in vivo characterization,
targeting lead selection by the end of 2024.
"I’m extremely pleased to announce this proposed
merger with CohBar, which comes at a pivotal time for
Morphogenesis,” said Dr. James Bianco, Chief Executive Officer of
Morphogenesis. “We are gearing up to initiate our Phase 2/3
registration study for IFx-Hu2.0 early next year. Our technology
platforms have the potential to significantly increase the number
of cancer patients that respond to immunotherapies, such as
checkpoint inhibitors. This transaction serves as a significant
next step in the advancement of our important mission.”
About the Proposed Transaction,
Management & Organization
Under the terms of the merger agreement, subject
to stockholder approval, each holder of CohBar common stock as of
immediately prior to the closing of the transaction will be issued
a dividend equal to approximately 3.30 shares of CohBar common
stock on or about the effective date of the merger. On a pro forma
basis taking into account the concurrent financing described below
and the issuance of the stock dividend, pre-merger CohBar
equityholders are expected to collectively own approximately 15%
and pre-merger Morphogenesis equityholders are expected to
collectively own approximately 77%, respectively, of the common
stock of CohBar on a pro forma basis (assuming the exercise of all
in-the-money warrants and options then outstanding).
Upon execution of the merger agreement, CohBar
also entered into a stock purchase agreement with an affiliate of
an existing investor in Morphogenesis for a $15 million private
placement that is expected to close concurrently with the closing
of the proposed merger. The proceeds from the private placement
will be used to fund the advancement of the combined company’s
immunotherapy-focused development pipeline, with an anticipated
cash runway through 2024. Immediately following the closing of the
merger and the closing of the private placement, the shares issued
in the private placement are anticipated to represent approximately
9% of the common stock of CohBar on a pro forma basis (assuming the
exercise of all in-the-money warrants and options then
outstanding).
Additionally, pre-merger CohBar stockholders and
certain warrant holders of record will receive a contingent value
right (CVR). Holders of the CVR will be entitled to receive certain
payments from proceeds received by CohBar, if any, related to the
disposition of CohBar’s legacy mitochondrial assets for a period of
three years following the closing of the proposed merger.
The merger agreement has been approved by the
boards of directors of both companies and is subject to stockholder
approval of both companies and other customary closing conditions.
The proposed merger is expected to close in the third quarter of
2023.
Following the merger, the combined company will
be headquartered in Tampa, Florida, and the executive officers are
expected to be James Bianco, MD as Chief Executive Officer, and Dan
Dearborn, CPA as Chief Financial Officer. The merger agreement
provides that the board of directors of the combined company will
be composed of seven members, with five members initially
designated by Morphogenesis and two members initially designated by
CohBar.
Ladenburg Thalmann & Co., Inc. is acting as
the exclusive financial advisor and Gibson, Dunn & Crutcher LLP
is acting as legal counsel to CohBar. H.C. Wainwright & Co. is
acting as the exclusive financial advisor and Foley & Lardner
LLP is acting as legal counsel to Morphogenesis.
Conference Call & Webcast
Details
The companies plan to hold a joint conference
call and webcast today, May 23, 2023 at 8:30 AM ET to discuss the
Merger details.
Interested participants and investors may access
the conference call and webcast via the Investors section of the
CohBar website at www.cohbar.com. A webcast replay will be
available following the live event and will be accessible for 90
days.
About CohBar
CohBar (NASDAQ: CWBR) is a clinical-stage
biotechnology company leveraging the power of the mitochondria and
the peptides encoded in its genome to develop potential
breakthrough therapeutics targeting chronic and age-related
diseases with limited to no treatment options.
For additional company information, please visit
www.cohbar.com and engage with us on LinkedIn.
About Morphogenesis, Inc.
Morphogenesis is a Phase 2/3 clinical-stage
biotechnology company developing novel personalized cancer vaccines
and tumor microenvironment modulators to overcome resistance to
current immunotherapies. The company’s lead personalized cancer
vaccine candidate, IFx-Hu2.0, is designed to prime the activation
of the immune system to target and attack tumor cells by making
them look like bacteria. Through an intratumoral injection of a
gene coding for emm55, an immunogenic bacterial protein that is
then expressed on the surface of tumor cells, the immune system is
activated, providing a potent, multivalent systemic response
against all neoantigens in a patient’s tumor. Morphogenesis is
preparing to initiate a single Phase 2/3 registration trial as an
adjunct to Keytruda® (pembrolizumab) in first line treatment for
metastatic Merkel Cell Carcinoma (MCC). The company’s follow-on
personalized cancer vaccine candidate, IFx-Hu3.0, is being
developed as an intravenously delivered proprietary construct of
emm55 mRNA targeting CD22 for the treatment of B-cell malignancies
like DLBCL. Additionally, the company is developing bi-functional
antibody drug conjugates (ADCs) designed to modify the tumor
microenvironment by targeting the delta receptor on MDSCs.
For additional information, please visit
www.morphogenesis-inc.com.
No Offer or Solicitation
This communication is not intended to and shall
not constitute an offer to buy or sell or the solicitation of an
offer to buy or sell any securities, or a solicitation of any
proxy, consent, authorization, vote or approval, nor shall there be
any sale of securities in any jurisdiction in which such offer,
solicitation or sale would be unlawful prior to registration or
qualification under the securities laws of any such jurisdiction.
No offering of securities shall be made, except by means of a
prospectus meeting the requirements of the U.S. Securities Act of
1933, as amended.
Additional Information About the
Proposed Transaction for Investors and Stockholders
In connection with the proposed transaction
between CohBar and Morphogenesis (the “Proposed Transaction”,
CohBar intends to file relevant materials with the U.S. Securities
and Exchange Commission (the “SEC”), including a registration
statement on Form S-4 that will contain a proxy
statement/prospectus of CohBar. This press release is not a
substitute for the registration statement or for any other document
that CohBar may file with the SEC in connection with the Proposed
Transaction. COHBAR URGES INVESTORS AND STOCKHOLDERS TO READ THE
REGISTRATION STATEMENT, PROXY STATEMENT/PROSPECTUS AND ANY OTHER
RELEVANT DOCUMENTS THAT MAY BE FILED WITH THE SEC, AS WELL AS ANY
AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN
THEIR ENTIRETY IF AND WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL
CONTAIN IMPORTANT INFORMATION ABOUT COHBAR, MORPHOGENESIS, THE
PROPOSED TRANSACTION AND RELATED MATTERS. Investors and
stockholders will be able to obtain free copies of the proxy
statement/prospectus and other documents filed by CohBar with the
SEC (when they become available) through the website maintained by
the SEC at www.sec.gov. In addition, investors and stockholders
should note that CohBar communicates with investors and the public
using its website (www.cohbar.com), the investor relations website
(https://cohbar.com/investors) where anyone will be able to obtain
free copies of the proxy statement/prospectus and other documents
filed by CohBar with the SEC, and stockholders are urged to read
the proxy statement/prospectus and the other relevant materials
when they become available before making any voting or investment
decision with respect to the Proposed Transaction.
Participants in the
Solicitation
CohBar, Morphogenesis and their respective
directors and executive officers may be deemed to be participants
in the solicitation of proxies from stockholders in connection with
the Proposed Transaction. Information about CohBar’s directors and
executive officers including a description of their interests in
CohBar is included in CohBar’s most recent Annual Report on
Form 10-K (as amended), including any information
incorporated therein by reference, as filed with the SEC.
Additional information regarding these persons and their interests
in the transaction will be included in the proxy
statement/prospectus relating to the Proposed Transaction when it
is filed with the SEC. These documents can be obtained free of
charge from the sources indicated above.
Forward-Looking Statements
This news release contains forward-looking
statements that are not historical facts within the meaning of the
Private Securities Litigation Reform Act of 1995. Forward-looking
statements are based only on our current beliefs, expectations and
assumptions regarding the future of our business, future plans and
strategies, projections, anticipated events and other future
conditions. In some cases you can identify these statements by
forward-looking words such as “believe,” “may,” “will,” “estimate,”
“continue,” “anticipate,” “intend,” “could,” “should,” “would,”
“project,” “plan,” “expect,” “goal,” “seek,” “future,” “likely” or
the negative or plural of these words or similar expressions.
Examples of such forward-looking statements include but are not
limited to express or implied statements regarding CohBar’s or
Morphogenesis’ management team’s expectations, hopes, beliefs,
intentions or strategies regarding the future including, without
limitation, statements regarding: the Proposed Transaction and the
expected effects, perceived benefits or opportunities and related
timing with respect thereto, expectations regarding clinical trials
and research and development programs, in particular with respect
to Morphogenesis’ IFx-Hu2.0 product candidate, its IFx-Hu3.0
preclinical program, and its TME modulators development program,
and any developments or results in connection therewith; the
anticipated timing of the results from those studies and trials;
expectations regarding the use of capital resources, including the
net proceeds from the concurrent financing, and the time period
over which the combined company’s capital resources will be
sufficient to fund its anticipated operations; and the expected
trading of the combined company’s stock on the Nasdaq Capital
Market. In addition, any statements that refer to projections,
forecasts or other characterizations of future events or
circumstances, including any underlying assumptions, are
forward-looking statements. You are cautioned that such
statements are not guarantees of future performance and that actual
results or developments may differ materially from those set forth
in these forward-looking statements. Factors that could cause
actual results to differ materially from these forward-looking
statements include: the risk that the conditions to the closing or
consummation of the Proposed Transaction are not satisfied,
including the failure to obtain stockholder approval for the
Proposed Transaction; the risk that the concurrent financing is not
completed in a timely manner or at all; uncertainties as to the
timing of the consummation of the Proposed Transaction and the
ability of each of CohBar and Morphogenesis to consummate the
transactions contemplated by the Proposed Transaction; risks
related to CohBar’s and Morphogenesis’ ability to correctly
estimate their respective operating expenses and expenses
associated with the Proposed Transaction, as applicable, as well as
uncertainties regarding the impact any delay in the closing would
have on the anticipated cash resources of the resulting combined
company upon closing and other events and unanticipated spending
and costs that could reduce the combined company’s cash resources;
the occurrence of any event, change or other circumstance or
condition that could give rise to the termination of the Proposed
Transaction by either company; the effect of the announcement or
pendency of the Proposed Transaction on CohBar’s or Morphogenesis’
business relationships, operating results and business generally;
costs related to the merger; the outcome of any legal proceedings
that may be instituted against CohBar, Morphogenesis, or any of
their respective directors or officers related to the merger
agreement or the transactions contemplated thereby; the ability of
CohBar or Morphogenesis to protect their respective intellectual
property rights; competitive responses to the Proposed Transaction;
unexpected costs, charges or expenses resulting from the Proposed
Transaction; legislative, regulatory, political and economic
developments; and additional risks described in the “Risk Factors”
section of CohBar’s Annual Report on Form 10-K for the fiscal year
ended December 31, 2022 filed with the SEC. Additional assumptions,
risks and uncertainties are described in detail in our registration
statements, reports and other filings with the Securities and
Exchange Commission and applicable Canadian authorities, which are
available on our website, and at www.sec.gov or www.sedar.com.
You are cautioned that such statements are not
guarantees of future performance and that our actual results may
differ materially from those set forth in the forward-looking
statements. The forward-looking statements and other information
contained in this news release are made as of the date hereof and
CohBar does not undertake any obligation to update publicly or
revise any forward-looking statements or information, whether as a
result of new information, future events or otherwise, unless so
required by applicable securities laws. Nothing herein shall
constitute an offer to sell or the solicitation of an offer to buy
any securities.
Investor Contacts:
CohBar, Inc.investors@cohbar.com
Morphogenesis, Inc.Jenene Thomas JTC Team, LLC
morphogenesis@jtcir.com
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