- Provies update on Prelininary Proxy Statement
Filing
- Highlights Approximate $11.6 M
cost-savings
EDINBURGH, Scotland, Feb. 14,
2024 /PRNewswire/ -- TC BioPharm (Holdings) PLC ("TC
BioPharm" or the "Company") (NASDAQ: TCBP) a clinical stage
biotechnology company developing platform allogeneic gamma-delta T
cell therapies for cancer and other indications, today announced a
shareholder update with a projected outlook for the current
year.
"The previous year was a time of significant
operational achievement for TC BioPharm," said Bryan Kobel,
Chief Executive Officer. "Despite strong headwinds throughout
financial markets, we announced capital infusions of
[approximately] $11.6 million while
streamlining efficiencies, successfully dosing the final patient
our ACHIEVE Study safety cohort and receiving FDA clearance of
the Company's investigational new drug (IND) application for a
Phase 1B study in relapse/refractory Acute Myeloid
Leukemia (AML). Additionally, we announced a new
collaboration with Queen Mary University of London to expand TCB-008 into anti-fungal and
anti-bacterial diseases, including non-dilutive funding to advance
the project at lesser/lessened cost to the Company. Our team
remains confident in TCB-008 as a therapeutic both as a monotherapy
and in combination with other cell and immune system focused
therapeutics, and looks forward to receiving interim data for the
ACHIEVE trial in 2024. In March of 2023, we gave the investment
community a roadmap of milestones we looked to complete in the
subsequent 9 months of 2023, and it's a great credit to the team
that the Company was able to successfully achieve each of these
milestones. We look forward/expect to continue this pattern of
execution in 2024 and hitting our key milestones as laid out."
Recent Company Updates
- FDA clearance of investigational new drug (IND) application for
a Phase 1B study in
relapse/refractory Acute Myeloid Leukemia (AML)
- The Company streamlined efficiencies and reduced overhead on
several fronts
- Formed a third-party manufacturing partnership in US with
Excellos
- Entered into a collaboration agreement with Queen Mary
University of London (QMUL) to
expand the platform into non-oncology indications. The QMUL project
received grant funding from The Impact Fund arm of QMUL, to
research the therapeutic potential of gamma-delta T cells for the
treatment of mucosal infections.
- Completed ACHIEVE Safety Cohort and received positive review
from the Data Safety Monitoring Board (DSMB).
2024 Potential Miletones
- Interim data review for ACHIEVE trial studying TCB-008 in Acute
Myeloid Leukemia
- Management is focused on leveraging existing strategic
relationships in order to execute partnerships and or
collaborations in combination with TCB-008.
- Platform expansion with Proof of Concept and preclinical work
completed for its anti-fungal/anti-bacterial program
- Expected budget savings of approximately $11.6M after eliminating redundancies and asset
prioritization efforts
Filing of Preliminary Proxy Statement
On February 9, 2024 the Company filed a preliminary
proxy statement with the Securities and Exchange Commission which
included a proposal to obtain shareholder approval, in accordance
with Nasdaq Marketplace Rule 5635(d), regarding the proposed sale,
issuance, or protential issuance by the Company of Ordinary Shares
or ADSs, in connection with certain non-public offerings, of the
Ordinary Shares or ADSs (and/or securities convertible into or
exercisable for Ordinary Shares or ADSs) equal to 20% or more
outstanding immediately prior to the issuance of such securities at
a price less than the lower of: (i) the closing price immediately
preceding the signing of the binding agreement, or (ii) the average
closing price of the ADSs for the five trading days immediately
preceding the signing of the binding agreement for the transaction,
subject to certain limitations. The Board of Directors of the
Company has not yet determined the terms and conditions of any
potential financing(s).. This filing is not a registration
statement andno shares have been issued or registered with the
Securities and Exchange Commission (SEC). TC BioPharm has taken
this step in light of converting from foreign filer status to a
domestic filer status, and in order to comply with NASDAQ
marketplace rules that are applicable to domestic filers.
Kobel continued, "In 2024, our goal is to make
additional strides throughout our pipeline of differentiated gamma
delta T cell therapies via a strategic and disciplined
approach. Receiving clearance on our IND from the U.S. FDA
of TCB-008 in Acute Myeloid Leukemia marks an important
milestone in maximizing our lead therapeutics' opportunity in the
category of blood cancers that we believe it is ideally suited to
address. Additionally, last week the Company filed a
preliminary proxy statement relating to the Nasdaq stock
exchange's requirement of obtaining shareholder approval for the
potential issuance of more than 20% of the shares
outstanding. This relates to being positioned to effectively
execute our business strategy over the coming 90 days, both in the
M&A arena and access to capital, and is a function of timing as
we shift from foreign filer status to domestic filer status for SEC
reporting and NASDAQ compliance purposes."
Forward-Looking Statements
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. All statements contained in this press release
that do not relate to matters of historical fact should be
considered forward-looking statements, including without limitation
statements regarding the Company's intent or ability to effect any
budget savings or execute on any M&A or capital raising
strategy. These statements are based on management's current
assumptions and are neither promises nor guarantees, but involve
known and unknown risks, uncertainties and other important factors
that may cause the Company's actual results, performance or
achievements to be materially different from any future results,
performance or achievements expressed or implied by the
forward-looking statements, including that the proposed issuance of
shares may not be approved by the Company's shareholders. For other
important factors that could cause actual results to differ
materially from the forward-looking statements in this press
release, please see the risks and uncertainties identified under
the heading "Risk Factors" in our Annual Report on Form 20-F for
the year ended December 31, 2022, and
our other reports filed with the SEC, all of which is available on
the Company's Investor Relations website at www.tcbiopharm.com and
on the SEC website at www.sec.gov. All forward-looking statements
reflect the Company's beliefs and assumptions only as of the date
of this press release. The Company undertakes no obligation to
update forward-looking statements to reflect future events or
circumstances.
Important Additional Information And Where to
Find It
In connection with a General Meeting of
Shareholders to approve the proposed share issuance, the Company
has filed a preliminary proxy statement with the SEC and intends to
file a definitive proxy statement with the SEC that will be mailed
to its shareholders. This communication is not a substitute for any
proxy statement or other document that the Company may file with
the SEC in connection with the General Meeting. INVESTORS AND
SHAREHOLDERS OF TC BIOPHARM ARE URGED TO READ THE PROXY STATEMENT
AND OTHER RELEVANT DOCUMENTS FILED OR TO BE FILED WITH THE SEC IN
CONNECTION WITH THE GENERAL MEETING CAREFULLY AND IN THEIR ENTIRETY
BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED
STOCK ISSUANCE AND THE RISKS ASSOCIATED WITH THE PROPOSED STOCK
ISSUANCE. Investors and shareholders will be able to obtain,
without charge, a copy of the proxy statement and other relevant
documents filed with the SEC (as and when available) from the SEC's
website at www.sec.gov and on the Company's investor relations
website at www.tcbiopharm.com.
Participants in the Solicitation
This communication is neither a solicitation of a
proxy or consent nor a substitute for any proxy statement or other
filings that may be made with the SEC. Nonetheless, the Company,
its directors and executive officers and other members of
management and employees may be deemed to be participants in the
solicitation of proxies with respect to a solicitation by the
Company. Information regarding the Company's directors and
executive officers is contained in the Company's annual report on
20-F, which was filed with the SEC on May 1,
2023. You may obtain these documents without charge from the
SEC's website at www.sec.gov and on the Company's investor
relations website at www.tcbiopharm.com.
About TC BioPharm (Holdings) PLC
TC BioPharm is a clinical-stage biopharmaceutical company
focused on the discovery, development and commercialization of
gamma-delta T cell therapies for the treatment of cancer with human
efficacy data in acute myeloid leukemia. Gamma-delta T cells are
naturally occurring immune cells that embody properties of both the
innate and adaptive immune systems and can intrinsically
differentiate between healthy and diseased tissue.
TC BioPharm is the leader in developing gamma-delta T cell
therapies, and the first company to conduct phase II/pivotal
clinical studies in oncology. The Company is conducting two
investigator-initiated clinical trials for its unmodified
gamma-delta T cell product line - Phase 2b/3 pivotal trial for OmnImmune® in treatment of
acute myeloid leukemia using the Company's proprietary allogeneic
CryoTC technology to provide frozen product to clinics
worldwide.
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SOURCE TC BioPharm