Filed
Pursuant to Rule 424(b)(4)
Registration
No. 333-280659
23,950 AMERICAN DEPOSITARY SHARES REPRESENTING 4,790,000 ORDINARY SHARES
AND
1,976,050 PRE-FUNDED WARRANTS TO PURCHASE UP TO
1,976,050
AMERICAN DEPOSITARY SHARES
AND 2,000,000 SERIES G WARRANTS TO PURCHASE UP TO 2,000,000 AMERICAN DEPOSITARY SHARES
(and
1,976,050 American Depositary Shares representing 395,210,000 ordinary shares underlying the Pre-Funded Warrants and 2,000,000
American Depositary Shares representing 400,000,000 ordinary shares underlying the Series G Warrants)
TC
BIOPHARM (HOLDINGS) PLC
We
are offering 23,950 American depositary shares, or ADSs representing 4,790,000 ordinary shares, par value £0.001
per share and 1,976,050 Pre-Funded Warrants representing 395,210,000 ordinary shares together with Series G warrants to purchase
up to 2,000,000 ADSs representing 400,000,000 ordinary shares (the “Series G Warrants”),. The ADSs and Warrants
will be sold in a fixed combination, with each ADS or Pre-Funded Warrant accompanied by one Series G Warrant to purchase one ADS.
The ADSs and Warrants are immediately separable and will be issued separately in this offering, but must be purchased together in this
offering. The public offering price for each ADS and accompanying Warrants is $1.00. The Series G Warrants will have an
exercise price per share of £0.78 ($1.00 translated for illustration to U.K. pounds at the rate of £1.00 to
$1.277 as of August 12, 2024), will be immediately exercisable and will expire on the first anniversary of the initial issuance
date.
We
are also offering to certain purchasers whose purchase of ADSs in this offering would otherwise result in the purchaser, together with
its affiliates and certain related parties, beneficially owning more than 4.99% (or, at the election of the purchaser, 9.99%) of our
outstanding ADSs immediately following the consummation of this offering, the opportunity to purchase, if any such purchaser so chooses,
pre-funded warrants, in lieu of ADSs that would otherwise result in such purchaser’s beneficial ownership exceeding 4.99% (or,
at the election of the purchaser, 9.99%) of our ADSs. The public offering price of each pre-funded warrant will be equal to the price
at which an ADS is sold to the public in this offering, minus $0.001, and the exercise price of each pre-funded warrant will be $0.001
per ADS. The pre-funded warrants will be immediately exercisable and may be exercised at any time until all of the pre-funded warrants
are exercised in full. For each pre-funded warrant we sell, the number of ADSs we are offering will be decreased on a one-for-one basis.
The ADSs and pre-funded warrants can only be purchased together in this offering but will be issued separately and will be immediately
separable upon issuance. This prospectus also relates to the ADSs issuable upon exercise of the Series G Warrants and the pre-funded
warrants sold in this offering.
There
is no established public trading market for the Warrants and pre-funded warrants, and we do not expect a market to develop. We do not
intend to apply for listing of the Warrants and pre-funded warrants on any securities exchange or other nationally recognized trading
system. Without an active trading market, the liquidity of the warrants will be limited.
This
offering will terminate on August 20, 2024, unless we decide to terminate the offering (which we may do at any time in
our discretion) prior to that date. We will have one closing for all the securities purchased in this offering.
Our
ADSs are listed on the Nasdaq Capital Market, or Nasdaq, under the symbol “TCBP”. On August 12, 2024, the closing trading
price for our ADSs, as reported on Nasdaq, was $3.96 per ADS.
On August 5, 2024, we effected a change to the ratio of our ADSs
to our ordinary shares from one ADS representing twenty (20) ordinary shares to one ADS representing two hundred (200) ordinary shares,
or the ADS Ratio Change. Except as otherwise indicated, all information in this prospectus, including the number of ADSs being offered
and the assumed offering price gives retroactive effect to the ADS Ratio Change.
We
are a “foreign private issuer,” and an “emerging growth company” each as defined under the federal securities
laws, and, as such, we are subject to reduced public company reporting requirements. See the section entitled “Prospectus Summary—Implications
of Being an Emerging Growth Company and a Foreign Private Issuer” for additional information.
Investing
in our securities involves a high degree of risk. Before buying any ADSs, you should carefully read the discussion of material risks
of investing in the ADSs and the company. See “Risk Factor Summary” beginning on page 27 for a discussion of information
that should be considered in connection with an investment in our securities.
Neither
the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined
if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.
| |
|
Per
ADS and Warrant
|
|
|
Per
Pre-Funded
Warrant
and
Warrant |
|
|
Total |
|
| Public
offering price |
|
$ |
1.000 |
|
|
$ |
0.999 |
|
|
$ |
2,000,000 |
|
| Proceeds
to us (before expenses) (1) |
|
$ |
1.000 |
|
|
$ |
0.999 |
|
|
$ |
2,000,000 |
|
| (1) |
We
estimate the total expenses of this offering payable by us will be approximately $0.2
million. |
We
anticipate that delivery of the securities against payment will be made on or about August 14, 2024, subject to satisfaction of
customary closing conditions.
Prospectus
dated August 12, 2024
TABLE
OF CONTENTS
We
have not authorized anyone to provide information
different from that contained in this prospectus, any amendment or supplement to this prospectus or in any free writing prospectus prepared
by us or on our behalf. We do not take any responsibility for, and can provide no assurance as to the reliability of, any
information other than the information in this prospectus, any amendment or supplement to this prospectus, and any free writing prospectus
prepared by us or on our behalf. Neither the delivery of this prospectus nor the sale of the ADSs means that information contained in
this prospectus is correct after the date of this prospectus. This prospectus is not an offer to sell or the solicitation of an offer
to buy the ADSs in any circumstances under which such offer or solicitation is unlawful.
You
should rely only on the information contained in this prospectus and any free writing prospectus prepared by or on behalf of us or to
which we have referred you. We have not authorized anyone to provide you with information that is different.
We are offering to sell the ADSs, and seeking offers to buy the ADSs, only in jurisdictions where offers
and sales are permitted. The information in this prospectus is accurate only as of the date of this prospectus, regardless of the time
of delivery of this prospectus or any sale of the ADSs.
For
investors outside of the United States: We have not done anything that would permit this offering or possession
or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than in the United States. Persons
outside the United States who come into possession of this prospectus must inform themselves about and observe any restrictions relating
to this offering and the distribution of this prospectus outside the United States.
ABOUT
THIS PROSPECTUS
Unless
the context requires otherwise, in this prospectus TC BioPharm (Holdings) plc (formerly TC BioPharm (Holdings) Limited, which was re-registered
as a public limited company on January 10, 2022) and its subsidiaries (“Subsidiar(y/ies)”), and TC BioPharm Limited (our
principal trading subsidiary) shall collectively be referred to as “TCB,” “the Company,” “the Group”,
“we,” “us,” and “our” unless otherwise noted.
On
December 17, 2021, prior to our initial public offering, the Company undertook a corporate reorganization pursuant to which TC
BioPharm (Holdings) plc became the group holding company. The Company in turn effected a forward split of its ordinary shares on a
10 for 1 basis. On November 18, 2022 the Company undertook a reverse share split such that fifty issued ordinary share were
exchanged for one new ordinary share. On December 15, 2023, we effected a change to the ratio of our ADSs to our ordinary shares
from one ADS representing one (1) ordinary share to one ADS representing twenty (20) ordinary shares. Except as otherwise indicated,
all information in this prospectus, including the number of ADSs being offered and the assumed offering price gives retroactive
effect to the ADS Ratio Change. On August 5, 2024, we effected a change to the ratio of our ADSs to our ordinary shares
from one ADS representing twenty (20) ordinary shares to one ADS representing two hundred (200) ordinary shares, or the ADS Ratio
Change. Except as otherwise indicated, all information in this prospectus gives retroactive effect to the ADS Ratio Change.
As a result
of the share splits and ratio change, all references included in this document to units of ordinary shares or per share amounts are reflective
of the forward and reverse share splits for all periods presented. In addition, the exercise prices and the numbers of ordinary shares
issuable upon the exercise of any outstanding options to purchase ordinary shares were proportionally adjusted pursuant to the respective
anti-dilution terms of the share-based payment plans.
The
consolidated financial statement data as at December 31, 2023 and 2022, and for the years ended December 31, 2023 and 2022 have been
derived from our consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles,
or GAAP. The December 31, 2023 and 2022 consolidated financial statements were audited in accordance with the standards of the Public
Company Accounting Oversight Board (United States).
You
should rely only on the information provided or incorporated by reference in this prospectus. We have not authorized anyone
to provide you with additional or different information. We do not take responsibility for, nor can we provide assurance as to
the reliability of, any other information that others may provide. We are not making an offer to sell these securities
in any jurisdiction where the offer or sale is not permitted. You should assume that the information in this prospectus, or any related
free writing prospectus is accurate only as of the date on the front of the document and that any information incorporated by reference
is accurate only as of the date of the document incorporated by reference, regardless of the time of delivery of this prospectus or any
related free writing prospectus, or any sale of a security, unless we indicate otherwise. Our business, financial condition, results
of operations and/or prospects may have changed since those dates.
This
prospectus includes statistical, market and industry data and forecasts which we obtained from publicly available information and independent
industry publications and reports that we believe to be reliable sources. These publicly available industry publications and reports
generally state that they obtain their information from sources that they believe to be reliable, but they do not guarantee the accuracy
or completeness of the information. Although we believe that these sources are reliable, we have not independently verified the information
contained in such publications. In addition, assumptions and estimates of our and our industry’s future performance are necessarily
subject to a high degree of uncertainty and risk due to a variety of factors, including those described in the “Risk Factor Summary”.
These and other factors could cause our future performance to differ materially from our assumptions and estimates.
Some
of our trademarks and trade names are used in this prospectus, which are intellectual property owned by the Company. This prospectus
also includes trademarks, trade names, and service marks that are the property of other organizations. Solely for convenience, our trademarks
and trade names referred to in this prospectus appear without the TM symbol, but those references are not intended to indicate,
in any way, that we will not assert, to the fullest extent under applicable law, our rights, or the right of the applicable licensor
to these trademarks and trade names.
No
offer of these securities will be made in any jurisdiction where the offer is not permitted.
ENFORCEABILITY
OF CIVIL LIABILITIES
TCB
is a corporation organized under the laws of Scotland. Substantially all of TCB’s assets and half of its directors and executive
officers are located and reside, respectively, outside the United States. Because of the location of TCB’s assets and board members,
it may not be possible for investors to serve process within the United States upon TCB or those persons with respect to matters arising
under the United States federal securities laws or to enforce against TCB or persons located outside the United States judgments of United
States courts asserted under the civil liability provisions of the United States federal securities laws.
TCB
understands that there is doubt as to the enforceability in Scotland and the United Kingdom, in original actions or in actions for enforcement
of judgments of United States courts, of civil liabilities predicated solely upon the federal securities laws of the United States insofar
as they are fines or penalties. In addition, awards of punitive damages in actions brought in the United States or elsewhere may be unenforceable
in Scotland and the United Kingdom by reason of being a penalty.
TC
BioPharm (North America) Inc., a Delaware corporation, with a registered office at Business Filings, Inc. 108 West 13th Street, Wilmington,
Delaware 19801, has been appointed agent to receive service of process in any action against TC BioPharm (Holdings) plc in any state
or federal court in the State of New York.
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
TCB
discusses in this prospectus its business strategy, market opportunity, capital requirements, product introductions and development plans
and the adequacy of the Company’s funding. Other statements contained in this prospectus, which are not historical facts, are also
forward-looking statements. TCB has tried, wherever possible, to identify forward-looking statements by terminology such as “may,”
“will,” “could,” “should,” “expects,” “anticipates,” “intends,”
“plans,” “believes,” “seeks,” “estimates” and other comparable terminology.
TCB
cautions investors that any forward-looking statements presented in this prospectus, or that TCB may make orally or in writing from time
to time, are based on the beliefs of, assumptions made by, and information currently available to, TCB. These statements are based on
assumptions, and the actual outcome will be affected by known and unknown risks, trends, uncertainties and factors that are beyond its
control or ability to predict. Although TCB believes that its assumptions are reasonable, they are not a guarantee of future performance,
and some will inevitably prove to be incorrect. As a result, its actual future results can be expected to differ from its expectations,
and those differences may be material. Accordingly, investors should use caution in relying on forward-looking statements, which are
based only on known results and trends at the time they are made, to anticipate future results or trends. Certain risks are discussed
in this prospectus and also from time to time in TCB’s other filings with the Securities and Exchange Commission (“SEC”).
This
prospectus and all subsequent written and oral forward-looking statements attributable to the Company or any person acting on its behalf
are expressly qualified in their entirety by the cautionary statements contained or referred to in this section. The Company does not
undertake any obligation to release publicly any revisions to its forward-looking statements to reflect events or circumstances after
the date of this prospectus.
In
particular, you should consider the risks provided under “Risk factors” in this prospectus and in the Form 10-K for the fiscal
year ended December 31, 2023 as filed with the Securities and Exchange Commission (the “2023 Form 10-K”) incorporated by
reference in this prospectus.
PROSPECTUS
SUMMARY
This
summary highlights information contained elsewhere, or incorporated by reference, in this prospectus and does not contain all the information
that you should consider in making your investment decision. Before deciding to invest in our securities, you should read this entire
prospectus carefully, including the sections of this prospectus entitled “Risk Factors” beginning on page 27 of this prospectus,
the information included in any free writing prospectus that we have authorized for use in connection with this offering, and the documents
incorporated by reference herein. Unless the context requires otherwise, in this prospectus TC BioPharm (Holdings) plc (formerly TC BioPharm
(Holdings) Limited, which was re-registered as a public limited company on January 10, 2022) and its subsidiaries (“Subsidiar(y/ies)”),
and TC BioPharm Limited (our principal trading subsidiary) shall collectively be referred to as “TCB,” “the Company,”
“the Group”, “we,” “us,” and “our” unless otherwise noted. Unless otherwise indicated,
all share amounts and prices reflect the consummation of the ADS Ratio Change.
Corporate
Overview
TCB
is based in Scotland and is a clinical-stage biopharmaceutical company focused on developing novel immunotherapy products
based on our proprietary allogeneic gamma delta T (GD-T) cell platform. Harnessing the innate ability of GD-Ts has enabled us to develop
a range of clinical-stage cell therapies designed to combat cancer and viral infection.
In-house
clinical studies have demonstrated that our unmodified allogeneic GD-T products are (i) well tolerated and (ii) show preliminary evidence
of disease modification in patients with the late-stage blood cancer, known as acute myeloid leukemia (AML). Based on clinical data generated
by us believe that unmodified GD-Ts have the potential to treat all blood cancers.
TCB
now is embarking on phase 2b-into-pivotal (phase 3) clinical studies with a view to launching its first oncology product for the treatment
of AML. Clinical results generated thus far have enabled us to obtain FDA orphan drug status for treatment of AML.
In
addition to unmodified allogenic GD-Ts for treatment of blood cancers, we are also developing an innovative range of genetically-modified
CAR-T products for treatment of solid cancers. We believe that solid cancers are more difficult to treat than blood cancers and may require
the addition of a CAR “chimeric antigen receptor” (i) to help therapeutic cells to “navigate” into diseased cancerous
tissue and (ii) to retain therapeutic cells in-situ at the lesion for maximal efficacy (increased persistence).
In
order to manufacture our portfolio of allogeneic products, TCB selects the highest quality GD-T cells from healthy donors, activate the
cells and grow them in large numbers at our in-house GMP-compliant manufacturing facility before administration to a patient in order
to target and then destroy malignant or virally-infected tissues. TCB believes that we have introduced a step-change to our manufacturing
platform by implementing a freeze-thaw process that will allow product to be shipped from cleanroom to patient without any shelf-life
issue. Resulting products, TCB believes, will be more cost-effective and straightforward to ship form cleanroom to clinic.
At
this stage, TCB does not have any approved products. Accordingly, TCB has not generated any revenue from the sale of products, and TCB
does not expect to generate any such revenue unless and until it obtains regulatory approvals for, and commercialize any of, our product
candidates. In the future, TCB will seek to generate revenue primarily from product sales and, potentially, regional or global collaborations
with strategic partners, which may produce license fee income.
See
“Business - Overview” in 2023 Form 10-K incorporated by reference in this prospectus.
Intellectual
Property
We
have a strong portfolio of patents covering manufacture and commercialization of GD-T cell products and their modification via CAR-T
(summarized below). Our technology platform and clinical programs have enabled us to raise over $100 million in grant, equity and collaboration
funding since becoming operational in 2017. This financing has allowed us to enhance and expand our clinical and preclinical programs
as well as build our team of world-class scientists.
The
following table provides an overview of our core technology platforms, technology assets and competencies across the business. Additional
details of our intellectual property portfolio are provided below.
| ASSET
SUMMARY |
|
ATTRIBUTES |
| |
|
|
| GD-T
Vehicle |
|
● |
Readily
available and expanded to high numbers. |
| |
|
● |
Not
MHC-restricted, therefore no graft vs host disease – an allogeneic platform. |
| |
|
● |
Pre-programmed
tropism for infiltration of diseased tissue. |
| |
|
● |
Multiple
modes of innate cytotoxicity and coordinating a wider immune response. |
| |
|
● |
Clinical
tolerability of the allogeneic vehicle demonstrated at high dose level. |
| |
|
● |
Naturally
arising in different subtypes offering a menu of vehicles with unique properties. |
| |
|
|
|
| Allogeneic
Cell Banks |
|
● |
Donor
GD-Ts selection based on highest therapeutic quality. |
| |
|
● |
Reproducible
product with low cost-of-goods compared with autologous (patient-bespoke) therapies, can be frozen-shipped, thawed at clinic. |
| |
|
● |
Well
understood clinical and regulatory pathway to commercialization. |
| |
|
|
|
| Co-stimulatory
CAR-T |
|
● |
Elimination
of off-tumor toxicity. |
| |
|
● |
Reduction
of cytokine release from killing healthy cells. |
| |
|
● |
Reliance
on natural T cell activation and no tonic signaling |
| |
|
● |
Antigen
expression on healthy tissue tolerated – greatly expanded range. |
| |
|
● |
Ability
to use multiple co-stimulatory receptors to add functionality. |
| |
|
|
|
| Integrated
Business Model |
|
● |
Full
control of critical stages of development projects, which increases speed and reliability of development and production, optimizes
operations to our specialized products and materially reduces our cost base |
| |
|
● |
No
pass-through or transaction costs form external service providers, which increases efficiency and speed of development and manufacturing
and materially reduces our cost base |
| |
|
● |
In-house
clinical management ensures best chance of clinical success and avoids use of very expensive clinical management in early-stage trials,
materially reducing our cost base. |
The
strength of our patents involves complex legal and scientific questions and can be uncertain.
We
actively seek to protect the intellectual property and proprietary technology that we believe is important to our business, including
seeking, maintaining, enforcing and defending patent rights for our therapeutics and processes, whether developed internally or licensed
from third parties. Our success will depend on our ability to obtain and maintain patent and other protection including data/market exclusivity
for our therapeutic products and platform technology, preserve the confidentiality of our know-how and operate without infringing the
valid and enforceable patents and proprietary rights of third parties.
Our
policy is to seek to protect our proprietary position generally by filing an initial priority filing at the U.K. Intellectual Property
Office, or UKIPO. This is followed by the filing of a patent application under the Patent Co-operation Treaty claiming priority from
the initial application(s) and then progressing to national applications in, for example, the United States, Europe, Japan, Australia,
New Zealand, China and Canada. In each case, we determine the strategy and territories required after discussion with our patent professionals
to ensure that we obtain relevant coverage in territories that are commercially important to us and our GD-T therapeutic candidates.
We will additionally rely on data exclusivity, market exclusivity and patent term extensions when available, including as relevant exclusivity
through orphan or pediatric drug designations. We also rely on trade secrets and know-how relating to our underlying platform technology
and therapeutic products. Prior to making any decision on filing any patent application, we consider, with our patent professionals,
whether patent protection is the most sensible strategy for protecting the invention concerned or whether the invention should be maintained
as confidential.
As
of June 5, 2024, we own 16 granted patents and 11 patent applications in 3 families, and have an exclusive license to an additional 1
family of 14 granted patents and 8 patent applications. Consistent with the filing strategy outlined above, all of our applications are
either UK applications, PCT applications or national phase applications derived from a corresponding PCT application. These patents and
patent applications include claims directed to our therapeutic products and platform technology or other manufacturing and process technology
to further enable our therapeutic products and manufacturing methods.
See
“Business - Intellectual Property” in our 2023 Form 10-K incorporated by reference in this prospectus.
Our
Business Strategy
We
have taken a step-wise approach to clinical development and commercialization. To achieve this, we have made the clinical transition
from autologous GD-Ts to allogeneic GD-Ts, improving our process for optimization of our product based on data and new technologies.
The Company plans to maximize the value of TCB-008 and future iterations by expanding the use case for the product, effectively believing
TCB-008 (and future such iterations) to be a “platform therapeutic” based upon its safety profile and the in-house knowledge
of GD-Ts and TCB-008. Additionally, the Company plans to opportunistically add to the asset base of the Company around other cell therapy
approaches and such technologies where we can leverage our expertise and facilities. Our commercialization strategy is to introduce
products firstly in blood cancers (AML initially), and pending data, in other disease indications and in solid tumors as a combination
therapeutic.
Our
strategic objective is to build a global therapeutic business with an extensive portfolio of GD-T cell-based products with the potential
to significantly improve the outcomes of patients with cancer and infectious disease. In order to achieve our objective, we are focused
on delivering success in the following areas:
Progress
unmodified GD-T2s into Phase 2/3 clinical trials for the treatment of blood cancers
Having
generated meaningful clinical data showing our product is well-tolerated in late-stage AML patients with no remaining treatment options,
we commenced phase 2b-into pivotal (phase 3) clinical studies under the trial name ‘ACHIEVE’, with OmnImmune® during
2022 in AML patients who have failed to respond adequately to induction therapy. The aim is to provide a form of salvage therapy which
will either stabilize the patient, thereby preventing disease progression, or delay the requirement for human stem cell transplant. Our
initial trial centers are in the UK and we are currently dosing patients in this trial. Working on the premise that other blood cancers
should respond to GD-Ts in a similar manner to AML, TCB plans to conduct clinical studies for OmnImmune® in other hematological malignancies
in future.
Unmodified
GD-T2s for use in the treatment of fungal infections
Gamma-delta
T cells are dysfunctional in patients with many severe viral diseases and TCB anticipates that its unmodified gamma delta T cell therapy
platform will be used in due course to treat viral infections as well as cancers under the name ImmuniStim®. For example, during
2022 TCB developed a clinical trial protocol to treat patients with COVID 19. Because of the progress of the disease and absence of appropriate
trial patients this trial is not currently being progressed, although we expect to continue our infectious disease program in future.
Grow
our business operations to support the increasing number of clinical-phase products in development
We
believe that our existing cell and gene manufacturing facility in the UK has the capacity to support our committed clinical development
plans. We plan to continue to build upon this to support expansion of our product pipelines to new assets and to grow our clinical team.
We also will work closely with vendors to embrace emerging technologies in our manufacturing operations that are appropriate and optimized
for our products to continually improve the quality and efficiency of our manufacturing systems. We believe that maintaining in-house
control of these activities is critical to effective and efficient progression and we will continue to seek to build integrated business
functions where possible.
Apply
our discovery engine to target further diseases and add additional functionality to our products
As
a platform technology, our co-stimulatory CAR-T GD-T cell system has a wealth of potential options to build added functionality into
our cell-based platform. We plan to continue to innovate and partner in the field to augment our drug products and introduce next generation
attributes. We also plan to continue to innovate our manufacturing and supply chains to efficiently scale our processes and simplify
the interface with patients and healthcare professionals, whilst continually seeking to reduce manufacturing costs to improve patient
access.
Expand
our intellectual property portfolio and acquire additional technologies to augment our strong IP position
We
intend to continue building on our technology platform, comprised of intellectual property, proprietary methods and know-how in the field
of GD-T cells. These assets form the foundation for our ability, not only to strengthen our product pipeline, but also to successfully
defend and expand our position as a leader in the field of GD-T based immune-oncology.
See
“Business - Business Strategy” in our 2023 Form 10-K incorporated by reference in this prospectus.
TCB’s
Strengths
Our
clinical trials have provided very strong evidence of drug-toleration and some preliminary evidence of clinical benefit.
Our
clinical trial of TCB001 involved treatment of patients with autologous unmodified GD-Ts. In a phase 1b/2a dose-ranging safety study
(maximum total dose 30x109 cells) we saw no evidence of drug-related severe adverse events. A total of eight patients were
treated with escalating doses of TCB001, and no treatment-related toxicities were reported during the full six-week therapeutic course.
Data from OmnImmune® (TCB002) suggests an excellent tolerability, with no observed Host versus Graft Disease (HvGD) and some preliminary
indication of clinical benefit. OmnImmune® (TCB002) has been granted Orphan Drug Designation by the FDA.
Our
CAR-T platform is centered on development of safer and more widely applicable therapeutic candidates and associated process and manufacturing
capabilities.
Our
proprietary co-stimulatory CAR-T technology platform covers identification of target cancer antigens, successful design and engineering
of target sequences, preclinical safety testing and optimized manufacturing processes suitable for producing therapeutic candidates for
use in clinical trials and commercialization. We believe the platform will enable development of additional GD-T cell therapeutic candidates
targeting cancers that have previously been difficult to treat. We believe the products will be demonstrably safer than the current generation
of AB T cell CAR-T products because they will not attack healthy non-cancerous cells and augment the natural biological process rather
than bypassing it.
We
have identified a large and growing pool of cancer targets for which we can develop additional therapeutic candidates.
We
have identified over 20 antigens that are preferentially expressed in cancer cells and have established ongoing research programs to
develop several of these into our GD-T platform. Within the terms of our agreement, bluebird bio, we have first right of refusal on a
further three oncology targets. Each antigen target presents an opportunity to target many cancer types and therefore presents multiple
potential represents a development, collaboration and/or an out-licensing opportunity as each target could be used to target specific
cancer types. Growing the pipeline of products built on our co-stimulatory CAR-T and reaching patients is our priority.
We
have historically entered collaborative arrangements with partners (bluebird bio, Inc (now 2seventybio). (USA) and Nipro Corporation
(Japan), which involve funded or partly funded preclinical collaboration. It is uncertain at this time whether TCB will receive any significant
revenues from these collaborations.
We
retain control of key business elements, such as product manufacture and clinical research.
Whilst
many companies contract out product manufacture, quality systems and clinical trial management, we have elected to build these skills
in-house. TC BioPharm has a GMP (Good Manufacturing Practice) cleanroom facility where our products are manufactured. We also retain
all the quality support systems such as product testing and release of final product to the clinic. Keeping these systems in-house allows
the Company to control all aspects of the manufacturing process whilst significantly reducing costs of goods (CoGs). Further saving on
costs are accrued by in-house manufacture, as contract manufacturing organizations (CMOs) will typically charge several times more than
the actual costs to maintain their profit margins. Rather than fully outsource our clinical trial management, data management and pharmacovigilance,
we maintain an inhouse clinical team that partners with a contract clinical research organization (CRO) for data management and pharmacovigilance
services. The inhouse clinical team conducts and manages our own clinical trials in-house. In addition to significant cost savings, this
allows us to build a strong working relationship with physicians who are treating the cancer patients; we believe this is key to successful
product development as the physicians participating in our clinical studies will also be our future customers. We believe that retaining
control of key elements of our business such as GMP manufacture and clinical operations, has allowed TC BioPharm to move quickly and
efficiently since incorporation.
We
continue to file new patent applications from new in-house product development, and have a strong growing intellectual property portfolio
to protect our products and proprietary platform.
We
have a strong intellectual property portfolio covering the key aspects of our manufacturing processes and product platforms. Our in-house
product development team are dedicated to developing new therapeutic candidates and optimizing current manufacturing processes. All of
our patent families are currently in various stages of the patent approval process, and as leaders in the path towards the commercialization
of GD-Ts we hold significant first-mover advantage captured by trade secrets and know-how.
Our
policy of developing strategic alliances has and will provide additional support for product development and commercialization.
We
believe that strategic alliances, both historic and potential future alliances, have and will provide extensive experience in scale-up
and automation, culture media manufacture and post-authorization sales and marketing with regional expertise. Additionally, we expect
to use knowledge gained from our collaborations to improve development pathways for our unpartnered CAR-T therapeutic candidate programs.
We
have a highly knowledgeable and experienced management team with extensive industry experience and expertise in the United States and
in Europe.
Mr.
Kobel joined us as our Chief Executive Officer at the time of our IPO. Bryan brings a US presence to our executive team and over 15 years’
experience in Healthcare and Life Sciences capital markets. Martin Thorp, our Chief Financial Officer has over 40 years’ experience
in implementing capital strategies globally from seed investment to IPO. He was global CEO of Arthur Andersen Corporate Finance based
in New York.
Ability
to treat patients under the ‘Specials’ regulatory framework.
European
regulations (Regulation 167 of the Human Medicines Regulations 2012) set out the exemption from the requirement for a medicinal product,
placed on the market in the UK to hold a marketing authorization. This exemption flows from Article 5(1) of EU Directive 2001/83/EC,
which states that a member of the EU may, in accordance with legislation in force and to fulfil special needs, excludes from the provisions
of this Directive medicinal products supplied in response to a bona fide unsolicited order, formulated in accordance with the specifications
of an authorized healthcare professional and for use by an individual patient under his or her direct personal responsibility. Such an
unlicensed medicinal product may only be supplied in order to meet the special needs of an individual patient. An unlicensed medicinal
product should not be supplied where an equivalent licensed medicinal product can meet the special needs of the patient. Responsibility
for deciding whether an individual patient has “special needs” which a licensed product cannot meet should be a matter for
the doctor, dentist, nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber responsible for the
patient’s care.
In
terms of time and cost, the ‘Specials’ scheme is an attractive strategy. We believe that accumulating evidence by this route
could lead to rapid and wider product uptake through ‘off-label’ use.
TCB
believes it has certain identified strengths. These include:
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Clinical
trials that have provided strong evidence of safety and some preliminary indications of clinical benefit; |
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A
proprietary co-stimulatory CAR-T technology platform which we believe allows solid cancers to be treated without toxic side-effects; |
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Identification
of a large pool of cancer targets for which we believe we can develop therapeutic candidates; |
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Retention
of key business elements, especially in-house ability to manufacture cell-based product and conduct our own clinical research; |
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Robust,
and growing intellectual property portfolio protecting our products and proprietary platform; |
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Our
policy is to develop strategic collaborations with leading, international companies to work together with us to develop certain GD-T
CAR-T products into clinic. We believe that existing and future collaborations will provide us with experience in scale-up and automation,
and post-authorization sales and marketing; |
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A
highly knowledgeable and experienced management team with extensive industry experience and expertise in the United States and in
Europe; and |
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Ability
to treat patients under the ‘Specials’ regulatory framework in Europe. |
Our
Pipeline
What
are gamma delta T cells?
The
immune system plays an important role in targeting and destroying cancer cells. One component has evolved to scan the body for diseased
cells and eradicate them. In humans, GD-Ts arise as a number of different subtypes, defined by the sequence of the gamma and delta chains
of the T-cell receptor (TCR) on the cell surface. The gammadelta2 (GD-T2) subtype typically is the most abundant of these cells in healthy
humans, and its TCR- of anti-cancer immunity is GD-T cells – a type of white blood cell that express a variety of innate receptors,
which mediated signaling has been fully characterized by researchers.
Virally-infected
or cancerous cells become stressed and accumulate cell surface phosphoantigens (isopentenyl pyrophosphate – IPP’s) which
are recognized by GD-T2 cells. Our proprietary technology platform includes the manufacturing of unmodified and genetically modified
(CAR-T) GD-T cells as therapeutic candidates for use in clinical trials and commercialization. Almost all aspects of the value-chain
from product manufacture, quality systems, clinical and regulatory are operated in-house by TC BioPharm. We believe this is one of our
core competitive advantages, which we believe will contribute materially to our ability to overcome the challenging nature of developing
new products.
Human
lymphocytes comprise two groups of cells, B cells that generate antibodies for humoral immunity, and T cells that are responsible for
cellular immune responses. In healthy individuals, GD-T cells generally represent between 1% and 10% of peripheral blood T lymphocytes
and present one of the first lines of defense against a wide range of bacterial and viral pathogens, as well as surveillance for cancerous
cells. GD-T cells have the ability to regulate the initial immune response in several ways, including recruitment of other immune cells
such as neutrophils, dendritic cells and macrophages through production of various chemokines (Kirby et al., 2007). Depletion
of GD-T cells leads to impaired host defense to lung infections, for example (Moore et al., 2000; Lockhart et al., 2006).
The predominant subset of GD-T cells in the blood is the GD-T2, which mediates a variety of immune responses by direct cytolysis of cancer
cells and infected cells, development of memory phenotypes and modulation of other immune cells. The gammadelta1 (GD-T1) is a functionally
distinct subset of GD-T cells, which are a predominantly tissue resident population. GD-T1s are less well characterized, but their cytotoxic
function also has been described in different liquid and solid tumors (Siegers & Lamb, 2014).
Both
subsets of GD-T cells are thought to play a role in autoimmune disorders such as celiac disease, rheumatoid arthritis, autoimmune polyglandular
syndrome and sarcoidosis where such lymphocytes are seen to accumulate in high numbers.
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GD-T
cell killing a cancer cell.
(1)
A human GD-T (labelled ‘T’) identifies and scans (2) the surface of a cancer cell (labelled ‘C’). On contact
with the cancer cell (3) the GD-T releases perforin granules (stained red) into the cancer cell, rupturing its membrane (4) destroying
the cancer cell (adapted from – Enc Life Sci, Jul-2007). |
How
can GD-Ts be used to treat disease?
Cellular
immunotherapy is a form of treatment that harnesses the cells of the immune system to combat disease and is one of the most actively
pursued areas of research by biotechnology and pharmaceutical companies today. Interest in immunotherapy is largely driven by recent
compelling efficacy data in cancers and by the potential to achieve a cure or functional cure for some patients. While the field of immunotherapy
in cancer, in general, has achieved proof of concept and yielded significant durable responses in multiple tumor types, there remain
major tumor types such as colon, breast, and prostate cancers as well as patient groups within responsive tumors, that do not respond
to current immunotherapy treatments. One theory to explain this non-responsiveness is that certain tumors require direct immune stimulation.
T cell-based technologies seek to deliver activated T cells towards malignancies to initiate an immune response. The primary challenges
in the field have been to couple an acceptable efficacy and safety profile to successfully target solid tumors.
Adoptive
T cell transfer typically involves administration of autologous, allogeneic, or genetically-modified T cells (see footer below) into
a recipient host with the specific goal of boosting or transferring enhanced immunologic functionality. One of the most advanced cell-based
approaches – chimeric antigen receptor modified T cells (CAR-T) – has gained momentum. In a recent study, patients with refractory
B cell acute lymphoblastic leukemia were treated with autologous genetically-modified T cells, with almost 90% of patients showing a
marked improvement (Pan et al., 2017). Although the treatment is showing promise for specific tumor types, the safety profile
remains a concern, as serious adverse events have previously been reported following CAR-T therapy (Grigor et al., 2017). As a
consequence of safety issues related to this approach, regulatory approval may be more complex for this genetically modified T cell therapy
which effectively has two ‘starting materials’ – (i) the cellular component, and (ii) a lentiviral vector. The therapeutic
premise is well-established – T cells are transduced with a viral vector encoding a chimeric antigen receptor capable of recognizing
cancer-specific antigens, for example, CD19 which is commonly expressed on several tumors such as myeloma and B cell lymphomas. Transduction
is the process by which DNA is transferred from one cell to another by a virus; in this specific case DNA is introduced via a viral vector
(a tool commonly used by molecular biologists to deliver genetic material).
Following
transduction, the T cells are genetically primed to recognize and kill specific tumor cells expressing the target antigen. The process
involves extracting a patient’s T cells (or growing an allogeneic T cell bank), transfecting the cells with a gene for a chimeric-antigen-receptor
(CAR), and re-infusing transfected T cells into the patients. The use of cancer-specific cell therapies has gained momentum as several
companies demonstrated that genetically modified CAR-T cells are efficacious when directed against blood tumors. These breakthrough findings
have moved cell-based immunotherapy into the forefront of clinical oncology with two drugs now in the market.
T
lymphocytes have long been known to play an important role in cancer suppression and modulation of tumor growth and numerous experimental
studies have demonstrated the anti-cancer potential of GD-T lymphocytes. Indeed, GD-T cells can recognize a number of specific tumor-associated
molecules including non-peptidic antigens (IPP’s – isopentenyl pyrophosphate) and immune surveillance stress signals (such
as HSP60/70, MICA, MICB, and ULBP) present on the surface of transformed cells. The GD-T cell overexpresses IL-2 receptors and this cytokine
is necessary to activate them (Kjeldsen-Kragh, 1993). On recognizing a tumor cell, GD-T cells exert their anti-cancer properties via
release of both perforin and of granzyme, a serine protease which enters the target cell to trigger cell death (apoptosis). Our research
efforts are focused entirely on targeting tumors in ways that may result in an improved therapeutic index and that have potential applications
in solid tumors as well as hematological malignancies. In contrast to conventional AB CAR-T cells, our GD-T cell technology provides
greater specificity in targeting tumors through recognition of IPP-expressing cells, whilst avoiding on-target, off-tumor effects on
healthy tissue lacking in IPPs.
Liquid
cancers
For
cell therapies to be effective several parameters need to be addressed. These include (i) viability, (ii) homing to the tumor, (iii)
persistence at the tumor, and (iv) target-specificity.
Use
of unmodified GD-Ts to treat blood cancers addresses all the above factors. We believe that (i) we have demonstrated therapeutic cells
remain viable when injected into the bloodstream of cancer patients; (ii) our research shows GD-Ts injected into the bloodstream remain
in-situ; and (iii) they persist for up to 100 days after administration. Moreover, we believe we have demonstrated that certain late-stage
blood cancer patients treated with multiple GD-T doses have shown significantly positive responses. These findings lead TCB to believe
that all patients with similar blood cancers may respond to GD-T cell therapy in a positive manner.
Solid
cancers
We
believe that it may be necessary to use CAR-T technology (i) to maximize therapeutic cell homing into the solid tumor site, and (ii)
to increase GD-T cell persistence by ‘tethering’ the cell to antigens present on the cancer cell surface.
In
order to overcome toxicities seen with conventional CAR-T approaches, we believe that we have developed a ‘co-stimulatory’
GD-T CAR which will only attack and kill cancerous cells whilst leaving healthy cells unharmed. This is important as many of the current
conventional CAR-T therapies cannot distinguish target antigens expressed on healthy cells from those on cancerous cells, which results
in various pathologies, including cytokine release syndrome, that in some cases had led to patient death. Such targeting of health cells
with conventional CAR-T makes their use in solid cancers difficult, as too much healthy tissue is likely to be destroyed as ‘collateral’
damage in the treatment process.
The
diagram below illustrates how TCB’s approach works, using the innate receptors on the GD-T cell surface to act as a ‘safety
switch’ – such receptors are generally not triggered by healthy cells, only by disease markers (IPP’s) on the surface
of cancerous or virally infected cells.
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B |
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Co-stimulatory
CAR-T: A) No GD-T cell activation in healthy cell. B) GD-T activation and cell-killing in cancer cell.
Autologous
cells are derived from ‘self’, using patients own cells to treat their specific disease
Allogeneic
cells are derived from donor material, giving rise to cell banks able to treat numerous patients
Genetically-modified
cells are typically engineered with a ‘chimeric’ receptor to target specific cancer antigens
Commercialization
of conventional CAR-T cell therapy has taken decades of high-quality research in academia and industry, and it has provided transformational
results for a number of patients with B cell malignancies. However, as noted, there are numerous barriers to widespread adoption, including:
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Severe
Toxicities. The significant risk of severe toxicities, especially cytokine release syndrome (CRS) and neurotoxicity occurring
up to 3 weeks from treatment. These toxicities have resulted in the need for implementing specific clinical pathways to certify staff
and facilities in the administration of the drugs and the management of the toxicities. |
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On-target,
off tumor toxicities. Conventional CAR-T products have no mechanism for discriminating between diseased and healthy cells. Activation
is governed solely by the expression of the target antigen, which can lead to toxicity when the target antigen is expressed on healthy
cells. In marketed products targeting CD19 (present in the vast majority of B cells), this can be tolerated as B-cell aplasia, albeit
with the need for regular long-term immunoglobulin replacement therapy. However, in experimental CAR-T products targeting other antigens
this has been shown to cause serious side-effects, up to and including fatality. |
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Complex
supply chains associated with autologous treatments. By definition, autologous treatments require the source cells to have been
collected from the patient. It therefore requires a personalized supply chain with multiple touch points and the manufacturing process
can only ever be performed on a single-patient batch size. This adds complexity to each treatment and has required the introduction
of completely new processes and infrastructure in able to commercialize the products. |
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Inherent
variability of the drug product. Each patient has a different cell population and so the starting material of each manufacturing
batch is always variable, leading to variable final product. This can be minimized during pre-screening, which eliminates some patients
from treatment, but there are still significant challenges in manufacturing to provide consistent batches of drug products and in
understanding which variables are critical to product quality. |
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High
list price of the products. The need for personalized manufacturing, new supply chain processes and management of acute and chronic
toxicities have all contributed to the high prices associated with the first CAR-T products reaching the market. In the USA, Kymriah®
has a list price of $475,000 for pediatric ALL, and Yescarta® lists at $373,000 for DLBCL patients. The associated treatment
costs and ongoing management can increase this price significantly |
The
combination of the co-stimulatory CAR, with GD-T cells, provides TCB with a proprietary platform which we believe addresses the problems
with existing CAR-T products in the following ways:
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Using
the natural T cell signaling of the GD-T cell will, we believe, result in less risk of hyperactivation and tonic signaling with an
overall reduction in the risk of CRS and less exhaustion of the cells. |
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The
requirement on cell activation remains on the endogenous GD-T cell TCR signal, which detects stress signals associated with cancerous
cells, so healthy cells are not targeted for destruction even if the target antigen is expressed and the CAR binds, thus off-tumor
toxicity is avoided. |
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Manufacturing
in batches of high dose numbers, without the complex patient collection of personalized supply chain steps, we believe will result
in a dramatic reduction in cost of goods. This will be reflected in a list price which is in line with current biologicals. With
the reduced likelihood of associated toxicities, the treatment and management costs should also be significantly lower, and the products
can be made available to many more patients as a result. |
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The
combination of a well-tolerated product and simplified supply chain (by virtue of our proprietary CryoTC freeze-thaw process), we
believe, will make the therapy suitable for administration in local oncology centers without patients having to locate in centralized
specialist centers of excellence, further reducing financial and logistic barriers to treatment. |
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The
tolerance of “off tumor” antigen binding without associated toxicity allows for a complete change in the current target
identification paradigm. Instead of identifying targets that are exclusively expressed on tumor cells, we believe our co-stimulatory
CAR-T approach confers an advantage to select targets that can be highly expressed on tumors and at low levels on healthy tissue.
We select targets based on their relative therapeutic index increase in expression, their homogeneity in tumors and the antigen density.
This allows us to target significantly more tumor associated antigens and to significantly expand the therapeutic index into higher
doses or repeat administration. |
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GD-T
cells have multiple roles in humans, possessing both innate and adaptive functions. One role is a sentinel surveillance cell, and
they are biologically primed to travel through tissue searching for sites of cellular stress. This ability to penetrate tissue makes
them advantageous agents for treating solid tumors. We can add additional function to the GD-T cells by using one or more co-stimulatory
CAR-T constructs to add targeting to appropriate antigen(s) and to provide armor or strategies to overcome environmental and immune
suppression in the tumor microenvironment. Therefore, we believe that the platform offers a promising approach to target the full
spectrum of cancer diseases. |
Viral
infections
GD-Ts
are natural killers of virally infected cells, as well as cancerous cells. We believe that our unmodified GD-T therapy offers substantial
potential as a first line of attack against future viral pandemics. During the COVID-19 pandemic, we took the opportunity to develop
a trial protocol to treat patients with COVID-19, which was approved by the MHRA. We are currently not progressing this trial because
of the absence of available patients given the progression of the disease; however we would consider conducting a phase 1b/2a trial if
more severe/pathogenic variants emerge and we believe that there is considerable opportunity to deploy our GD-T therapy in the treatment
of viral infections, including rapid response treatment of future epidemics and pandemics and selected acute viral infections. Whilst
our current focus is to prioritize cancer treatment we will seek opportunities to develop viral treatments either on our own or in partnership
in future Numerous peer-reviewed publications have demonstrated that GD-T cells innate killers of cells which have become virally infected.
Using Epstein-Barr virus infected cells as an exemplar, TCB has conducted pre-clinical studies to demonstrate that our GMP-compliant
manufacturing process results in GD-T with potent anti-viral cytotoxicity
Autologous
versus allogeneic
Commercially
available cell therapies typically are either autologous or allogeneic. Autologous products are taken from one donor (the patient) and
used to treat that same donor (self-to-self), whilst allogeneic products are usually taken from a single donor (not a patient) and used
as the starting material to treat a large number of different individuals (patients). GD-T lymphocytes are known to exert their biological
effect in a non-MHC restricted manner. This means the potential for graft-versus-host mediated rejection is significantly reduced if
allogeneic (non-self) cells are used as a treatment compared with many other immune cell therapies. As many patients with late-stage
cancer or severe viral infections are also immunosuppressed, potential for host-mediated rejection of allogeneic cells is also reduced.
When compared with autologous variants, commercial benefits of allogenic treatment include the following:
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significant
reduction in cost of goods; |
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product
can be campaign manufactured and stockpiled frozen; |
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increased
capacity to treat more patients; |
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logistics
of shipping product are simplified; |
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higher
doses of (reproducible) product are possible; and |
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product
is immediately available for acute disorders |
Our
strategy for developing an allogeneic solution for CAR-T is to select a pathway which will allow us to bring our products to patients
as quickly as possible. These concepts build upon decades of previous development in allogeneic cell therapies and have clear understanding
of development requirements in terms of manufacturing, clinical and regulatory execution.
Although
manufacture of allogeneic cell therapies allows product to be “pharmaceuticalized” by virtue of campaign manufacture and
storage, the approach is however not without technical and logistic challenges. To manufacture allogeneic banks, donor cells need to
be screened for numerous adventitious agents, including for example, HIV, hepatitis, CMV and syphilis. Additional tumorgenicity testing
is required, and assays conducted to ensure the cell bank is free from karyotypic aberrations. In order to overcome any potential for
rejection, TCB has developed allogeneic GD-T cell banks that are unlikely to elicit a graft-versus-host (GvH) or host-versus-graft (HvG)
immune response.
Donors
are screened and selected based on clinically-relevant history and then based on the proliferative capacity and phenotypic character
of their GD-Ts, based on a small volume blood draw and in-house assays. In this way, only good quality GD-T cells are selected for repeat
apheresis and banking. The banks are HLA-typed and become the starting material for all of the allogeneic CAR-T products. These banks
are cryopreserved in our facilities and can later be thawed, genetically engineered with the CAR, activated and expanded into final product,
before being frozen again as multiple individual doses of drug product.
Generation
of Gamma Delta T cells from IPSC cells
Identification
of appropriate donors whilst possible is challenging as only a limited number of batches can be created from a single donation. GD-T
cells can be routinely expanded from peripheral blood over 14 days. This provides a short window of opportunity for cell modification/engineering.
Induced
pluripotent stem cells (iPSCs) have the potential to overcome these issues because they are capable of unlimited proliferation and multidirectional
differentiation. In 2013, several research groups from Japan reported the successful reprogramming of αβT-cells, followed
by re-differentiation back to αβT cells (Vizcardo et al., 2013; Nishimura et al., 2013; Themeli et al.,
2013). While re-differentiated αβT cells-maintained antigen specificity, they were also characterized by higher proliferation
ability than an original T-cell clone.
We
hypothesized that GD-T derived iPSCs cells that carry the rearrangements at the TCRG and TCRD gene locus will be able to generate GD-T
but not αβT cells. Furthermore, iPSC cells will provide a vast opportunity for the gene-editing without any time constraints
of terminally differentiated cells.
Reprogramming
GD-T cells has proven to be a challenge, as these cells are not tolerant of cell sorting. Therefore, GD-T cells can be reprogrammed in
a bulk culture with the rest of peripheral blood cells or at the end of 14 days expansion, when the purity of GD-T is highest. After
several unsuccessful reprogramming attempts, we have optimized the conditions favoring GD-T cells reprogramming. In the last round of
reprogramming >50 clones were created. After extensive analysis of DNA rearrangements in δ- and γ-locus of 5 pre-selected
clones, it was confirmed that they are derived from GD-T cells with different TCR sequences.
IPSC
technology is an attractive approach for the limitless source of GD-T cells are successful progress in reprogramming has been demonstrated.
Further work is now required for the establishment of a GMP compatible T-cell differentiation protocol. Generation of GDT cells from
iPSC cells presents TCB with a vast opportunity for scaling without any time constraints of terminally differentiated cells.
Fresh
versus frozen product
Commercial
and clinical development of cellular therapy products will invariably require cryopreservation and frozen storage of cellular starting
materials, intermediates and/or final product.
Optimizing
cryopreservation is important to obtaining maximum yield and a consistent end-product. Suboptimal cryopreservation can lead not only
to batch-to-batch variation, lowered cellular functionality and reduced cell yield, but also to the potential selection of subpopulations
with genetic or epigenetic characteristics divergent from the original cell line.
Regulatory
requirements also impact on cryopreservation, requiring a robust and reproducible approach to freezing, storage and thawing of the product.
This requires attention to all aspects of the application of low temperatures; from the choice of freezing container and cryoprotectant,
the cooling rate employed and its mode of delivery, correct handling of the frozen material during storage and transportation, to eventual
thawing of the product by the end-user. Each of these elements influences all of the others to a greater or lesser extent and have been
taken into consideration as TCB moves from fresh to cryopreserved cell-based product.
In
a submission to UK regulators, we provided batch manufacture and supporting data, and TCB was granted approval to commence treatment
of cancer patients using frozen allogeneic product. This represents a significant milestone for TCB, as we pioneer use of cryopreserved-donated
cells to treat cancer. Obvious benefits include increased product reproducibility, ability to ship product globally on request and significant
economy of scale (through batch manufacture and storage).
Clinical
studies – unmodified GD-Ts in blood cancer
Management
of acute myeloid leukemia (AML) is based on intensive chemotherapy and/or stem cell transplant, but these therapies lead to high relapse
rates amongst treated patients. Particularly for the relapsed/refractory AML population or those who are not eligible for alloHSCT or
intensive chemotherapy, the therapy options are limited, and patients are often placed in experimental protocol therapies or palliative
care. As a result, there is a need for additional therapies, particularly for these cohorts.
GD-T
cells have emerged as a promising therapy due to their ability to specifically target cancer cells. Nonclinical studies performed in
AML cell lines suggest that GD-T cells specifically target AML tumor cells and lead to cell lysis in vitro (Kirk et al., 1993).
Additionally, in xenotransplantation animal models, GD-T cells obtained from healthy volunteers specifically target AML cells and result
in increased survival and diminished tumor burden in NOD mice (Gertner-Dardenne et al., 2012). Similarly, in vitro experiments
conducted by TCB further support such findings whilst providing evidence that OmnImmune® (TCB002) specifically targets stress induced
cells and effectively kills AML cells lines.
In
the clinic, allogeneic treatment in AML patients in the phase 1b/2a trial OmnImmune® (TCB002) has shown our product is well-tolerated
with some preliminary evidence of anticancer activity. Firstly, there were no signs of graft vs. host disease (GvHD) following therapy
and secondly, CR (complete response) and MLFS (morphologic leukemia free state) were observed. Earlier results with autologous product
demonstrated good tolerability. For the allogeneic product, OmnImmune® (TCB002), additional procedures were included to prevent GvHD
(e.g. AB T cell depletion). Literature reports were also supportive of the use of OmnImmune® (TCB002) in cancer patients. The phase
1b/2a trial tested OmnImmune® (TCB002) in active relapsed or refractory AML who were not eligible for or did not consent to high
dose salvage chemotherapy and/or allogeneic hematopoietic stem cell transplantation (alloHSCT). The trial was conducted to identify a
tolerable dose and better understand the safety of this therapy in the chosen indication as well as generate preliminary information
on potential clinical benefit. The primary, secondary and exploratory endpoints were as follows:
Primary
endpoints:
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Assessment
of adverse events (Aes) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0, vital signs and evaluation of laboratory
parameters |
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Incidence
of dose-limiting toxicities (DLTs) during the first 28 days after γδ T cell administration. |
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Establish
Maximum Tolerated Dose (MTD) of OmnImmune® |
Secondary
endpoints:
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Complete
Remission (CR) rate |
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Overall
survival (OS) |
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Quality
of life determined by EORTC QLQ-C30 questionnaire |
Exploratory
endpoints:
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Changes
in γδ T cell count and phenotype before and after OmnImmune® infusion |
No
formal statistical analysis was planned. The incidence of DLTs were to be summarized descriptively by γδ T cells dose for
evaluable patients. The recommended dose would be determined as the greatest with an incidence of DLTs no greater than 1/3. All other
data including efficacy results were summarized descriptively by γδ T cells dose.
The
trial enrolled 8 patients and healthy donors aged >18 years.
Clinical
outcome
Seven
patients were treated with OmnImmune® (TCB002). The eighth patient could not be dosed because the study was terminated as a result
of the COVID-19 pandemic, which prevented the importation of investigational product from Scotland to the Czech Republic. No safety concerns
were raised during Safety Review Committee (SRC) meetings. No treatment related Serious Adverse Reactions (SARs) were reported in any
of the patients who were enrolled in the trial. No grade 3≥ OmnImmune® (TCB002) treatment related toxicities were noted in any
of the treated patients. No dose-limiting toxicities were observed and no emergency safety measures have occurred for any subjects receiving
OmnImmune® (TCB002). Two patients at 28 days post-treatment achieved a CR (one patient) or MLFS (one patient); another patient was
classified as attaining stable disease with > 50% reduction in bone marrow blast count; one additional patient exhibited reduction
in blast levels at 14 days; and one patient had disease progression (see table below). One patient (PRA1-5003) died 21 days after TCB002
due to bilateral pneumonia, determined unrelated to study medication. One patient (PRA1-5010) was withdrawn because of the COVD-19 pandemic
before bone marrow aspiration on day 28 post-treatment. These preliminary indications of anticancer activity were not expected given
the refractory profile of the enrolled patients.
The
EORTC QLQ-C30 questionnaire resulted in scoring from six of the seven patients dosed with OmnImmune® (TCB002) for varying periods
of time depending on their study duration. At 7 days post dosing, the average QoL score from six patients had decreased from 55.7 to
47.2 out of a possible maximum of 100. This negative impact on QoL reflects the well characterized side effects of preconditioning therapy
with cyclophosphamide and fludarabine given between 6 and 2 days prior to OmnImmune® (TCB002) administration. The score remained
lower in the four patients assessed at 28 days at a level of 50.0. In the two patients (one CR and one MLFS) who were assessed at the
end of the study (week 24), both had recovered to an improved QoL score, each of 67.0.
FDA
Orphan Drug Designation
About
60 million people living in the European Union (EU) and USA suffer from a rare disease. The European Medicines Agency (EMA) and FDA play
a central role in facilitating the development and authorization of medicines for rare diseases, which are termed ‘orphan medicines’
in the medical world. Developing medicines intended for small numbers of patients has little commercial incentive under normal market
conditions. Therefore, the EU and USA offer a range of incentives to encourage the development of designated orphan medicines.
The
general therapeutic strategy for the treatment of AML has not changed substantially over the past 30 years. Excluding APL (which should
be treated with trans-retinoic acid), AML management is based primarily on induction, incorporating an anthracycline and cytarabine,
and consolidation therapy, and/or allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT). Induction/consolidation therapy leads
to high CRs rates in those who are eligible for treatment and present a favorable risk profile.
Several
novel agents are in various stages of development for the treatment of AML. Novel approaches include antibody-based immunotherapy and
adoptive cell therapy that aim to improve anti-leukemia T cell function, such as the therapies developed by TCB (OmnImmune®).
OmnImmune®
(TCB002) was initially studied in patients with active relapsed or refractory AML who are not eligible or do not consent to high dose
salvage chemotherapy and/or alloHSCT. In July 2019, OmnImmune® (TCB002) was granted ‘orphan medicine’ status from the
FDA for Acute Myeloid Leukemia (AML). TCB intends to conduct a further clinical phase 2/3 study (OmnImmune® (TCB008-001)) in 2021/2
aimed at treating earlier stage AML patients.
Summary
of TCB’s phase 1b/2a clinical trial in patients with fourth-line-of-treatment acute myeloid leukemia. Subsequent to the completion
of this study TCB commenced phase 2b into 3 (pivotal) patient treatment during H1, 2022.
Pipeline
and plan
Our
future pipeline is focused on treating liquid cancers with our unmodified GD-T therapies and the treatment of solid cancers with next-generation
allogeneic GD-T CAR-T therapies.
Our
unmodified cell therapy, used in the treatment of Acute Myeloid Leukemia, is supplied under the name OmnImmune.
OmnImmune®
is an allogeneic unmodified GD-T (GD-T2) cell product. Donor-derived GD-T cells for proliferative capacity, were activated and expanded
in our manufacturing facility before being infused into the patient as part of our OmnImmune® (TCB002) phase 1 trial. This trial
was completed in H1 2020 at the Institute of Hematology and Blood Transfusion in Prague, Czech Republic. Having generated meaningful
clinical data showing our product is well-tolerated in late-stage AML patients with no remaining treatment options, TCB commenced a phase
2b-into pivotal (phase 3) clinical studies (with OmnImmune®) during 2022 in AML patients who have failed to respond adequately to
induction therapy. The aim is to provide a form of salvage therapy which will either stabilize the patient, thereby preventing disease
progression, or delay the requirement for human stem cell transplant. Our initial trial centers are in the UK. Working on the premise
that other blood cancers should respond to GD-Ts in a similar manner to AML, TCB plans to conduct clinical studies for OmnImmune®
in other hematological malignancies in future. The initial phase 1b/2a trials were undertaken using fresh cell-based product under the
program number TCB002. For ease of reference, when discussing that specific trial, we refer the program as OmnImmune® (TCB002). The
subsequent planned phase 2b-into pivotal (phase 3) clinical studies uses a frozen cell-based product under the program number TCB008-001.
When discussing that specific trial, we refer the program as OmnImmune®.
We
plan to develop a range of allogeneic co-stimulatory GD-T CAR pre-clinical drug candidates which will target antigens expressed on a
number of solid tumor types.
TCB
has generated in-vitro preclinical data as part of our CAR-T program which demonstrated that GD-Ts are very high purity and can be CAR-transduced
with high efficiency (see diagram below). Gamma delta cell purity and transduction efficiency have been measured using flow cytometry.
CAR positive cells were measured by a detection reagent labelled with the fluorophore Phycoerythrin (PE). Flow cytometry analysis used
the parameters of side scatter height (SSC-H) and PE area (PE-A) to define the cell populations. This is demonstrated in the figure below
comparing non-transduced (NTD) and transduction with a co-stimulatory CAR construct (co-stim CAR).
We
have also demonstrated that following transduction with different CAR constructs, GD-T’s can be effectively and reproducibly expanded
in-vitro whilst exhibiting increased cytotoxicity in a zoledronate-dependent manner (see diagrams below – zoledronate-dependency
reflects TCB’s proprietary process for commercial expansion of GD-T’s). The CAR constructs contained different endodomains
including DNAX-activating protein 10 (DAP-10) and the high affinity IgE receptor (FcR) with no endodomain (no-endo) and non-transduced
(NTD) as controls. These data outline the key preclinical parameters investigated in advance of progressing our CAR-T products into clinical
trials. TCB has engaged with UK regulators to discuss the design of GD-T CAR phase1b/2a clinical studies (specifically relating to patient
dosing and quality systems).
Peripheral
blood mononuclear cells (PBMCs) were initiated into culture and GD-T cells expansion stimulated by zoledronic acid. On day 2 of expansion,
cells were transduced with lentiviral vectors (LVV) to deliver the indicated CAR constructs. After routine feeding through the expansion
process, cells were harvested on day 14 and the total cell number, fold expansion and viability of GD-T cells evaluated. Data present
a compilation of experiments across multiple individual donors (N=9; n=1-5).
Corporate
Information
Our
principal executive offices are located in Scotland, United Kingdom, with a mailing address of Maxim 1, 2 Parklands Way, Holytown, Motherwell,
ML1 4WR, United Kingdom and our telephone number at that location is +44 (0) 141 433 7557. Our website address is https://www.tcbiopharm.com.
The information contained on, or that can be accessed through, our website is not part of this prospectus. We have included our website
address in this prospectus solely as an inactive textual reference.
Implications
of Being an “Emerging Growth Company”
We
are an “emerging growth company,” as defined in Section 2(a) of the Securities Act of 1933, as amended, or the Securities
Act. As such, we are eligible to, and intend to, take advantage of certain exemptions from various reporting requirements applicable
to other public companies that are not “emerging growth companies” such as not being required to comply with the auditor
attestation requirements in the assessment of our internal control over financial reporting of Section 404 of the Sarbanes-Oxley Act
of 2002, or the Sarbanes-Oxley Act. We could remain an “emerging growth company” for up to five years, or until the earliest
of (a) the last day of the first fiscal year in which our annual gross revenue exceeds $1.235 billion, (b) the date that we become a
“large accelerated filer” as defined in Rule 12b-2 under the Securities Exchange Act of 1934, as amended, or the Exchange
Act, which would occur if the market value of all our ordinary shares, including those represented by the ADSs, that are held by non-affiliates
exceeds $700 million as of the last business day of our most recently completed second fiscal quarter, or (c) the date on which we have
issued more than $1 billion in nonconvertible debt during the preceding three-year period.
Implications
of being a “Foreign Private Issuer”
As a company incorporated
in Scotland that is listed on Nasdaq Capital Market (“Nasdaq”), the Company is subject to Nasdaq corporate governance listing
standards. The Company determined it qualified as a foreign private issuer under federal securities laws as of June 28, 2024, the last
business day of its most recently completed second fiscal quarter.
We
are subject to the information reporting requirements of the Securities and Exchange Act of 1934, as amended, the Exchange Act, that
are applicable to “foreign private issuers,” and under those requirements we file reports with the SEC. As a foreign private
issuer, we are not subject to the same requirements of the SEC applicable to U.S. domestic issuers. Under the Exchange Act, we are subject
to reporting obligations that, in certain respects, are less detailed and less frequent than those of U.S. domestic reporting companies.
For example, we are not required to issue quarterly reports, proxy statements that comply with the requirements applicable to U.S. domestic
reporting companies, or individual executive compensation information that is as detailed as that required of U.S. domestic reporting
companies. We also have four months after the end of each fiscal year to file our annual report with the SEC and are not required to
file current reports as frequently or promptly as U.S. domestic reporting companies. Our officers, directors and principal shareholders
are exempt from the requirements to report transactions in our equity securities and from the short-swing profit liability provisions
contained in Section 16 of the Exchange Act. As a foreign private issuer, we are not subject to the requirements of Regulation FD (Fair
Disclosure) promulgated under the Exchange Act. In addition, as a foreign private issuer, we are permitted to follow certain home country
corporate governance practices instead of those otherwise required under the Nasdaq Stock Market rules for domestic U.S. issuers and
are not required to be compliant with all Nasdaq Stock Market rules as of the date of our initial listing on Nasdaq as would domestic
U.S. issuers These exemptions and leniencies will reduce the frequency and scope of information and protections available to you in comparison
to those applicable to a U.S. domestic reporting company. We intend to take advantage of the exemptions available to us as a foreign
private issuer during and after the period we qualify as an “emerging growth company.”
Recent
Developments
Exercise
of Pre-funded Warrants
During
January 2024, pre-funded warrants representing 139,800 ADSs were exercised in three separate tranches.
Issuances
of ADSs and grants of options to purchase ADSs
On
February 29, 2024, the Renumeration Committee of the Board of Directors approved a grant of options to purchase ADSs to the Company’s
executive officers and non-employee directors under the Company’s 2021 Shares Option Scheme (the “Plan”) and agreed
to cancel all shares options previously issued to such persons. Each non-employee director received an option to purchase 4,176
ADSs, or ADSs representing 835,200 Ordinary Shares at an exercise price of $10.90 per ADS, which is equal to the closing price
of the Company’s ADSs on the Nasdaq Capital Market on January 31, 2024. Martin Thorp, the Company’s Chief Financial Officer,
received an option to purchase 17,712 ADSs, or ADSs representing 3,542,440 Ordinary Shares at an exercise price of $10.90
per ADS, which is equal to the closing price of the Company’s ADSs on the Nasdaq Capital Market on January 31, 2024. Bryan Kobel,
the Company’s Chief Executive Officer received an option to purchase 38,161 ADSs, or ADSs representing 7,632,120 Ordinary
Shares at an exercise price of $10.90 per ADS, which is equal to the closing price of the Company’s ADSs on the Nasdaq Capital
Market on January 31, 2024. All share options that were issued vest immediately upon issuance.
On
March 8, 2024, Bryan Kobel, the Chief Executive Officer of the Company agreed to (a) defer the payment of accrued but unpaid contractual
pension benefits owed to him in the amount of $66,000 for a period of 9 months and (b) convert an aggregate amount of $24,760 of accrued
but unpaid contractual pension benefits owed to him into 476,153 ordinary shares, par value £0.0001 per share of Company, based
on a price per share equal to the closing price of the Company’s ADSs on the Nasdaq Capital Market on March 7, 2024 divided by
two hundred (200), or the then effective ADS ratio.
In
addition, the board of directors approved a grant of options to Mr. Kobel purchase 15,300 ADSs, or ADSs representing 3,060,000
Ordinary Shares at an exercise price of $20.00 per ADS, which is a premium to the closing price of the Company’s ADSs on
the Nasdaq Capital Market on March 7, 2024. The options granted to Mr. Kobel were issued under the Company’s 2021 Plan. All share
options that were issued vested immediately.
Exercise
of Series D Warrants
On
March 12, 2024, the Company issued 62,375 ADS representing 12,475,000 ordinary shares of the Company upon exercise of outstanding
Series D warrants resulting in gross cash proceeds to the Company of £986,398 (approximately $1,263,000).
April
2024 LOI
On
April 1, 2024, we entered into a non-binding letter of intent (the “Asset LOI”) with an unnamed cell therapy company. (the
“Asset Seller”), regarding the potential acquisition (the “Proposed Asset Transaction”) by the Company of the
following assets of Asset Seller: a Solid Tumor tool kit, a NK Cell Manufacturing tool kit, and two CAR-NK programs (the “Assets”).
In exchange for the sale of the Assets to the Company, the Company will pay to the Asset Seller a combination of cash and equity at closing,
as well as milestone payments based upon certain clinical achievements.
The
Asset LOI only represents a mutual indication of interest regarding the Proposed Asset Transaction and the terms of the Proposed Asset
Transaction are subject to a number of contingencies, including the completion of customary due diligence and the negotiation and execution
of definitive agreements. Upon execution of the definitive agreements, the completion of the transaction will be subject to, among other
matters, satisfaction of the conditions negotiated therein, the Company having secured adequate financing, and receipt of all third party
(including governmental) approvals, licenses, consents, and clearances, as and when applicable. There can be no assurance that the Proposed
Asset Transaction will be completed on the terms contemplated in the Asset LOI or otherwise. In particular, the timing of closing of
any such transaction and the aggregate consideration that we may pay may materially differ from that currently contemplated by the Asset
LOI.
May
2024 LOI
On
May 1, 2024, we entered into a non-binding letter of intent (the “LOI”) with a private company (the “Seller”),
regarding a potential business combination (the “Proposed Transaction”) whereby the Company or a subsidiary of the Company
would acquire the Seller. In connection with the Proposed Transaction, the Company will pay to the Seller a cash purchase price equal
to $20 million less any amounts payable on any Seller indebtedness and issue American Depository Shares (the “ADSs”) representing
a number of the Company’s ordinary shares (the “Shares”) where the issue price of such Shares is equal to the average
price paid in a fundraising from new and existing shareholders in the Company raising in excess of US$50 million (the “Issue Price”),
such that the total value attributable to the Shares at closing is equal to US$20 million. In addition, the Seller will be entitled to
certain payments upon satisfaction of various development milestones.
The
LOI only represents a mutual indication of interest regarding the Proposed Transaction and the terms of the Proposed Transaction are
subject to a number of contingencies, including the completion of customary due diligence and the negotiation and execution of definitive
agreements. Upon execution of the definitive agreements, the completion of the transaction will be subject to, among other matters, satisfaction
of the conditions negotiated therein, the Company having secured adequate financing, and receipt of all third party (including governmental)
approvals, licenses, consents, and clearances, as and when applicable. There can be no assurance that the Proposed Transaction will be
completed on the terms contemplated in the LOI or otherwise. In particular, the timing of closing of any such transaction and the aggregate
consideration that we may pay may materially differ from that currently contemplated by the LOI.
May
2024 Warrant Inducement
On
May 6, 2024, the Company, entered into a letter agreement (the “Inducement Letter”) with certain holders (the “Holders”)
of existing Series E warrants (the “Existing Warrants”) to purchase ordinary shares represented by American depositary
shares (the “ADSs”) of the Company. The Existing Warrants were issued on December 21, 2023 and have an exercise price of
£15.81 per ADS. Each ADS represents twenty (200) ordinary shares of the Company.
Pursuant
to the Inducement Letter, the Holders agreed to exercise for cash their Existing Warrants to purchase an aggregate of 175,000
ADSs of the Company for cash and the payment of £0.99625 (US$1.25) per new warrant in consideration for the Company’s
agreement to issue new Series F warrants to purchase ordinary shares represented by ADSs (the “New Warrants”), as described
below, to purchase up to 70,000,000 of the Company’s ordinary shares represented by 350,000 ADSs (the “New Warrant
ADSs”). The Company received aggregate gross proceeds of approximately £3.1 million from the exercise of the Existing
Warrants by the Holders, prior to deducting placement agent fees and estimated offering expenses.
The
Company engaged H.C. Wainwright & Co., LLC (the “Placement Agent”) to act as its exclusive placement agent in connection
with the transactions summarized above and paid the Placement Agent a cash fee equal to 7.5% of the gross proceeds received from
the Holders’ exercise of their Existing Warrants and a management fee of 1% of the gross proceeds received from the Holders’
exercise of their Existing Warrants. The Company also reimbursed the Placement Agent for its expenses in connection with the exercise
of the Existing Warrants and the issuance of the New Warrants, $50,000 for fees and expenses of legal counsel and other out-of-pocket
expenses, and paid the Placement Agent for non-accountable expenses in the amount of $35,000 and a clearing fee of $15,950. Upon
any exercise for cash of any New Warrants, the Company has agreed to pay the Placement Agent
a cash fee of 7.5% of the aggregate gross exercise price paid in cash with respect the exercise of the New Warrants. In addition,
the Company granted warrants (“Placement Agent Warrants”) to the Placement Agent, or its designees, to purchase up to an
aggregate of 2,625,020 ordinary shares represented by 13,125 ADSs, which Placement Agent Warrants shall be substantially in the
same form as the New Warrants except that the Placement Agent Warrants will have an exercise price of £22.31.
The
closing of the transactions contemplated pursuant to the Inducement Letter occurred on May 8, 2024. The Company intends to use the net
proceeds from this offering to support its upcoming clinical trial focusing on relapse/refractory Acute Myeloid Leukemia, and for continuing
operating expenses and working capital.
The
Company also agreed to file a registration statement on Form S-3 (or other appropriate form if the Company is not then Form S-3 eligible)
covering the resale of the New Warrant ADSs issued or issuable upon the exercise of the New Warrants (the “Resale Registration
Statement”), within 30 days of the Closing Date, and to have such Resale Registration Statement declared effective by the SEC within
90 days following the Closing Date. The registration statement of which this prospectus is a part was filed and declared effective
on June 24, 2024 to fulfill our obligations under the Letter Agreement.
In
the Inducement Letter, the Company agreed not to issue any ADSs, ordinary shares or ordinary share equivalents or to file any other registration
statement with the SEC (in each case, subject to certain exceptions) until 30 days after the Closing Date. The Company also agreed not
to effect or agree to effect any variable rate transaction (as defined in the Inducement Letter) until one (1) year after the Closing
Date (subject to an exception).
Nasdaq
Compliance
As
previously reported in a Current Report on Form 8-K filed with the Securities and Exchange Commission (the “SEC”) on May
20, 2024 (the “May 20 8-K’), on May 15, 2024, the Company filed its Form 10-Q for the quarter ended March 31, 2024 (the “Form
10-Q”). As noted in the Form 10-Q, the Company was not in compliance with the minimum stockholders’ equity requirement under
Nasdaq Listing Rule 5550(b)(1) for continued listing on The Nasdaq Capital Market because its stockholders’ equity was below the
required minimum of $2.5 million (the “Minimum Stockholders’ Equity Requirement”) at March 31, 2024. As previously
reported in a Current Report on Form 8-K filed with the SEC on May 8, 2024, on May 6, 2024, the Company entered into a letter agreement
(the “Inducement Letter”) with certain holders (the “Holders”) of existing Series E warrants (the “Existing
Warrants”) to purchase ordinary shares represented by ADSs of the Company. Pursuant to the Inducement Letter, the Holders agreed
to exercise for cash their Existing Warrants to purchase an aggregate of 175,000 ADSs of the Company for cash and the payment
of £0.99625 (US$1.25) per new warrant in consideration for the Company’s agreement to issue new Series F warrants
to purchase ordinary shares represented by ADSs (the “New Warrants”) to purchase up to 70,000,000 of the Company’s
ordinary shares represented by 350,000 ADSs (the “New Warrant ADSs”). As noted above, on May 8, 2024, the Company
received aggregate gross proceeds of approximately £3.1 million (circa $3.9 million) from the exercise of the Existing Warrants
by the Holders, prior to deducting placement agent fees and estimated offering expenses. As a result, the
Company believes that due to the exercise of the Existing Warrants it is now in compliance with the Minimum Stockholders’ Equity
Requirement as at June 30, 2024.
On
May 24, 2024, the Company received written notification from the listing qualifications staff of the Nasdaq Stock Market, LLC (“Nasdaq”)
indicating that the Company was not in compliance with the Minimum Stockholders’ Equity Requirement, as of March 31, 2024. This
letter indicated that while Nasdaq estimates the Company is currently in compliance with the Minimum Stockholders’ Equity Requirement
it notes that based on the historical burn rate, without a significant transaction, the Company will not be in compliance as of the next
period ending June 30, 2024.
Since
the Company was previously granted an exception to the Minimum Stockholders Equity Requirement by a Nasdaq Hearings Panel and subsequently
regained compliance, it is subject to a Mandatory Panel Monitor in accordance with Nasdaq Listing Rule 5815(d)(4)(A).
The
Company requested and was granted a hearing before a hearing panel on July 16, 2024 at which it requested continued listing
on The Nasdaq Capital Market since it has returned to compliance and expects to continue to do so. On August 1, 2024, the Company
received written notification from Nasdaq that the hearing panel granted the Company’s request to continue its listing on Nasdaq
subject to compliance with the Minimum Stockholders’ Equity Requirement on or before August 15, 2024. There can be no assurance
that the Company will timely
evidence compliance with the terms of any extension that may be granted by the Nasdaq following the hearing.
The
Company has received a written notification from the listing qualifications staff of the Nasdaq Stock Market, LLC. dated August 1,
2024 indicating that the minimum closing bid price per share for its American Depositary Shares (the “ADSs”) was below
$1.00 for a period of 30 consecutive business days and that the Company did not meet the minimum bid price requirement set forth in
Nasdaq Listing Rule 5550(a)(2) (the “Rule”). Normally, a company would be afforded a 180-calendar day period to
demonstrate compliance with the Rule. However, pursuant to Listing Rule 5810(c)(3)(A)(iv), the Company is not eligible for any
compliance period specified in Rule 5810(c)(3)(A) due to the fact that the Company effected one or more reverse stock splits over
the prior two-year period with a cumulative ratio of 250 shares or more to one. Accordingly, this matter serves as an additional
basis for delisting the Company’s securities from Nasdaq. Nasdaq informed the Company that the hearing panel will consider
this matter in their decision regarding the Company’s continued listing on Nasdaq. As detailed below, the Company effected a
change in the ratio of its ADSs to ordinary shares which had the effect to increase proportionally the ADS trading price, although
the Company can give no assurance that the ADS trading price after the ADS ratio change will be proportionally equal to or greater
than the previous’ ADS trading price prior to the change. There can be no assurance regarding the outcome of the hearing panel’s determination with regard to this matter
and the associated delisting notice.
ADS
Ratio Change
On July 17, 2024, our Board of Directors approved the change in the ratio
of ADSs evidencing ordinary shares from one (1) ADS representing twenty (20) ordinary share to one (1) ADS representing two hundred (200)
ordinary shares, which will result in a one for 10 reverse split of the issued and outstanding ADSs (the “ADS Ratio Change”).
The ADS Ratio Change became effective on August 5, 2024. All ADS and related warrant information presented in this prospectus, including
our financial statements and accompanying footnotes, has been retroactively adjusted to reflect the reduced number of ADSs resulting from
the ADS ratio change.
THE
OFFERING
| Securities,
offered by us |
|
23,950
ADSs representing 4,790,000 ordinary
shares, 1,976,050 pre-funded warrants to purchase 1,976,050 ADSs representing 395,210,000 ordinary shares and together with
accompanying Series G warrants to purchase up to 2,000,000 ADSs representing 400,000,000 ordinary shares (the “Series
G Warrants”). The ADSs or prefunded warrants, respectively and Series G Warrants are immediately separable and will be issued
separately in this offering but must initially be purchased together in this offering. Each Series G Warrant has an exercise price
of £0.78 ($1.00 translated to U.K. pounds at the rate of £1.00 to $1.277 as of August 12,
2024) per ADS. See “Description of Securities”. We are also registering the ADSs issuable upon exercise of the pre-funded
warrants and the Warrants. |
| |
|
|
| ADSs |
|
Each
ADS represents twenty (200) ordinary shares. As a holder of ADSs, we will not treat you as one of our shareholders. The depositary,
through its custodian, will be the holder of the ordinary shares underlying the ADSs, and you will have the rights of a holder of
ADSs or beneficial owner (as applicable) as provided in the deposit agreement among us, the depositary and owners and holders of
ADSs from time to time. To better understand the terms of the ADSs we encourage you to read the deposit agreement, the form of which
is filed as an exhibit to the registration statement of which this prospectus forms a part. |
| |
|
|
| Series
G Warrants Offered |
|
We
are also offering Series G Warrants to purchase 2,000,000 ADSs representing 400,000,000 ordinary shares. The Series
G Warrants will expire on the first anniversary of the initial issuance date. The Warrants will be immediately exercisable and the
exercise price of each of the Warrants is £0.78 per ADS ($1.00 per ADS translated for illustration to U.S. dollars
at the rate of £1.00 to $1.277 as of August 12, 2024). |
| |
|
|
| Pre-Funded
Warrants Offered |
|
We
are also offering to certain purchasers whose purchase of ADSs in this offering would otherwise result in the purchaser, together
with its affiliates and certain related parties, beneficially owning more than 4.99% (or, at the election of the purchaser, 9.99%)
of our outstanding ADSs immediately following the closing of this offering, the opportunity to purchase, if such purchasers so choose,
pre-funded warrants to purchase ADSs, in lieu of ADSs that would otherwise result in any such purchaser’s beneficial ownership
exceeding 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding ADSs. Each pre-funded warrant will be exercisable
for one ADS. The purchase price of each pre-funded warrant will be equal to the price at which an ADS and accompanying Ordinary Warrant
is being sold to the public in this offering, minus $0.001, and the exercise price of each pre-funded warrant will be $0.001 ADS.
The pre-funded warrants will be exercisable immediately and may be exercised at any time until all of the pre-funded warrants are
exercised in full. This prospectus also relates to the ADSs issuable upon exercise of any pre-funded warrants sold in this offering.
For each pre-funded warrant we sell, the number of ADSs we are offering will be decreased on a one-for-one basis |
| |
|
|
| Term
of the offering |
|
This
offering will terminate on August 20, 2024, unless we decide to terminate the offering (which we may do at any time in our
discretion) prior to that date. |
| Ordinary
shares outstanding before this offering |
|
98,902,641
ordinary shares |
| |
|
|
| Warrants
outstanding before this offering |
|
Warrants
to purchase 383,817 ADSs |
| |
|
|
| Ordinary
shares to be outstanding after this offering, including ordinary shares represented by ADSs |
|
498,902,641
ordinary shares, assuming exercise of all
pre-funded warrants and no exercise
of the Warrants |
| |
|
|
| Use
of proceeds |
|
We
estimate that our gross proceeds from this offering will be approximately $2 million. This is based on a public offering price of
$1.00 per ADS, before
deducting estimated offering expenses payable by us. We intend to use the net proceeds of this
offering to advance our preclinical and clinical pipeline, and for continuing operating expenses and working capital. |
| |
|
|
| Risk
factors |
|
You
should read the “Risk Factors Summary” section within this prospectus and in Item 1A. “Risk Factors” in our
2023 Form 10-K included by reference in this prospectus, for a discussion of factors to consider carefully before deciding to invest
in our securities. |
| |
|
|
| Nasdaq
Capital market symbol |
|
ADSs
on the Nasdaq Capital Market under the symbol “TCBP.” |
The
number of our ordinary shares (including shares represented by ADSs) to be outstanding after this offering is based on 98,902,641 ordinary
shares outstanding as of August 12, 2024 and excludes:
| |
● |
106,585
ordinary shares issuable upon the exercise of options outstanding under our 2014 Share Option Scheme as of March 31, 2024, with a
weighted-average exercise price of £23.00 per share; |
| |
|
|
| |
● |
20,202
ordinary shares issuable upon the exercise of options outstanding under our 2021 Share Option Scheme, as of March 31, 2024, with
a weighted-average exercise price of $212.00 per share; |
| |
|
|
| |
● |
17,575,360
ordinary shares issuable upon the exercise of options outstanding under our 2021 Share Option Scheme, as of March 31, 2024, with
a weighted-average exercise price of $0.06 per share; |
| |
|
|
| |
● |
702,500
ordinary shares issuable upon the exercise of options outstanding under our 2021 Share Option Scheme, as of March 31, 2024, with
a weighted-average exercise price of $0.409 per share; |
| |
|
|
| |
● |
15,891
ordinary shares issuable upon the exercise of options outstanding, at a future date based on the achievement of certain clinical
and commercial milestones with an exercise price of £215.00 per share; and |
| |
|
|
| |
● |
76,763,300
ordinary shares issuable upon the exercise of warrants outstanding, as of August 12, 2024, with a weighted-average exercise
price of £0.184 per share. |
For
the description of the 2014 Share Option Scheme and 2021 Share Option Scheme please refer to the 2023 Form 10-K, which is incorporated
by reference herein.
Unless
otherwise stated, all information in this prospectus assumes no exercise of the outstanding options described above into ordinary shares
or ADSs, treats all restricted shares issued with outstanding restrictions to be vested as issued and outstanding shares, no exercise
of the Warrants issued in this offering and no sale of pre-funded warrants in this offering.
Except
as otherwise indicated all references to our articles of association in this prospectus refer to our articles of association, as amended
as currently in force for TC BioPharm (Holdings) plc at the date of this prospectus.
Summary
Consolidated Financial Data
The
following table summarizes our consolidated financial data as at the dates and for the periods indicated. The consolidated financial
statement data as of December 31, 2023 and 2022, and for the years ended December 31, 2023 and 2022 audited in accordance with
the standards of the Public Company Accounting Oversight Board (United States) have been derived from our consolidated financial statements,
which have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”).
The unaudited consolidated financial statement data as of March 31, 2024 and for the three months ended March, 2024 and
2023 have been derived from our unaudited condensed consolidated financial statements, which have been prepared in accordance with accounting
principles generally accepted in the United States (“U.S. GAAP”).
Our
historical results are not necessarily indicative of the results that may be expected in the future.
This
information should be read together with, and is qualified in its entirety by, our consolidated financial statements and the notes thereto.
You should read the following summary consolidated financial and other data in conjunction with “Item 5. Market for Registrant’s
Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities” and “Item 8. Financial Statements and
Supplementary Data”, our consolidated financial statements and the notes thereto and the other financial information included in
our 2023 Form 10-K annual report and in our 2024 Form 10-Q quarterly report and incorporated by reference in this prospectus.
| Consolidated Statement of Operations: | |
For the Year Ended | | |
For the Year Ended | |
| | |
December 31, 2023 | | |
December 31, 2022 | |
| | |
| | |
| |
| Revenue | |
£ | - | | |
£ | 3,844,532 | |
| | |
| | | |
| | |
| Operating expenses: | |
| | | |
| | |
| Research and development expenses | |
| 7,771,391 | | |
| 7,592,470 | |
| Administrative expenses | |
| 6,467,932 | | |
| 7,030,972 | |
| Administrative expenses - costs related to preparing for listing | |
| - | | |
| 1,305,087 | |
| Total operating expenses | |
| 14,239,323 | | |
| 15,928,529 | |
| Loss from operations | |
| (14,239,323 | ) | |
| (12,083,997 | ) |
| | |
| | | |
| | |
| Other income (expense): | |
| | | |
| | |
| Loss on modification of convertible loan | |
| (645,845 | ) | |
| (140,344 | ) |
| Change in fair value of derivative liability | |
| 8,052,581 | | |
| 16,064,945 | |
| Foreign currency losses | |
| (80,070 | ) | |
| (120,974 | ) |
| Interest expense | |
| (83,025 | ) | |
| (6,753,231 | ) |
| Total other income (expense), net | |
| 7,243,641 | | |
| 9,050,396 | |
| Net loss before income taxes | |
| (6,995,682 | ) | |
| (3,033,601 | ) |
| Income tax credit | |
| 1,088,729 | | |
| 1,720,000 | |
| | |
| | | |
| | |
| Net loss | |
£ | (5,906,953 | ) | |
£ | (1,313,601 | ) |
| | |
| | | |
| | |
| Weighted-average ordinary shares outstanding, basic and diluted (1) | |
| 6,178,423 | | |
| 687,199 | |
| Basic and diluted net loss per share (1) | |
£ | (0.96 | ) | |
£ | (1.91 | ) |
| | |
For
the Three Months
Ended | | |
For
the Three Months
Ended | |
| Consolidated Statement of Operations: | |
March 31, 2024 | | |
March 31, 2023 | |
| | |
| | |
| |
| Operating expenses: | |
| | | |
| | |
| Research and development expenses | |
| 1,298,942 | | |
| 1,934,304 | |
| Administrative expenses | |
| 2,142,714 | | |
| 2,231,461 | |
| Total operating expenses | |
| 3,441,656 | | |
| 4,165,765 | |
| Loss from operations | |
| (3,441,656 | ) | |
| (4,165,765 | ) |
| | |
| | | |
| | |
| Other income (expense): | |
| | | |
| | |
| Change in fair value of derivative liability | |
| 11,446 | | |
| 3,148,648 | |
| Other expense, net | |
| (2,386 | ) | |
| (17,794 | ) |
| Total other income (expense), net | |
| 9,060 | | |
| 3,130,854 | |
| Net loss before income taxes | |
| (3,432,596 | ) | |
| (1,034,911 | ) |
| Income tax credit | |
| 110,742 | | |
| 400,000 | |
| | |
| | | |
| | |
| Net loss | |
£ | (3,321,854 | ) | |
£ | (634,911 | ) |
| | |
| | | |
| | |
| Weighted-average common
shares outstanding, basic and diluted(1) | |
| 30,138,602 | | |
| 2,051,836 | |
| Basic and diluted net loss
per share(1) | |
£ | (0.11 | ) | |
£ | (0.31 | ) |
| Consolidated Statement of Financial Position
items: | |
March 31, 2024 | | |
December 31, 2023 | | |
December 31, 2022 | |
| | |
| | |
| | |
| |
| Cash and cash equivalents | |
£ | 980,955 | | |
£ | 2,462,609 | | |
£ | 4,808,060 | |
| Working capital (2) | |
| (560,816 | ) | |
| 950,326 | | |
| (1,716,361 | ) |
| Total assets | |
| 7,264,053 | | |
| 8,931,664 | | |
| 11,291,977 | |
| Total liabilities | |
| 6,183,565 | | |
| 6,246,434 | | |
| 10,960,712 | |
| Share capital | |
| 403,789 | | |
| 399,455 | | |
| 397,493 | |
| Additional paid-in capital | |
| 42,835,843 | | |
| 41,123,065 | | |
| 33,308,568 | |
| Accumulated deficit | |
| (42,159,144 | ) | |
| (38,837,290 | ) | |
| (33,374,796 | ) |
| Total shareholders’ equity | |
| 1,080,488 | | |
| 2,685,230 | | |
| 331,265 | |
| (1) |
On
November 18, 2022, the Company completed a reverse stock split of one (1) new share for every fifty (50) existing shares effective
November 21, 2022. As a result of the share split, all references in these financial statements and accompanying notes to units of
ordinary shares or per share amounts are reflective of the reverse share split for all periods presented. In addition, the exercise
prices and the numbers of ordinary shares issuable upon the exercise of any outstanding options to purchase ordinary shares were
proportionally adjusted pursuant to the respective anti-dilution terms of the share-based payment plans. |
| (2) |
Working
capital is defined as current assets less current liabilities. |
RISK
FACTOR SUMMARY
Our
business is subject to a number of risks and uncertainties, including those risks discussed at length in Item 1A. “Risk Factors”
in our 2023 Form 10-K incorporated into this prospectus by reference. These risks include among others those summarized below. Investing
in our company and its securities involves a high degree of risk. You should carefully consider the risks and uncertainties described
below, together with all of the other information in this prospectus, including the information incorporated by reference to our 2023
Form 10-K, before investing in our company and our securities. If any of these risks materialize, our business, financial condition,
operating results and prospects could be materially and adversely affected. In that event, the price or value of our ADSs in the public
market could decline, and you could lose part or all of your investment.
The
following is a summary of some of the principal risks we face. The list below is not exhaustive, and investors should read the risks
described under the heading “Risk Factors” in our 2023 Form 10-K incorporated by reference herein, as well as the additional
risks set forth in this section, in full.
| |
● |
We
have generated operating losses since inception and expect to continue to generate losses. We may never achieve or maintain profitability.
We will continue to require financing to continue to implement our business plan and sustain operations. |
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|
|
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● |
We,
as well as our independent registered public accounting firm, in relation to our financial position, have expressed substantial doubt
about our ability to continue as a going concern. The reasons for expressing that doubt in relation to our historical financial statements
remains relevant and applicable to this offering. |
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|
|
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● |
Our
lack of any approved products and our limited operating history may make it difficult for an investor to evaluate the success of
our business to date and to assess our future viability. |
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|
|
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● |
GD-T
cell therapies are a novel approach to treating cancers and infectious diseases, which have development risks and will require us
to obtain regulatory approvals for development, testing, commercialization, manufacturing and distribution. We may not achieve all
the required regulatory approvals or approvals may not be obtained as timely as needed. |
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● |
Because
GD-T cell therapies are a novel approach, potential side effects, and long-term efficacy, regulatory approval will require considerable
time for trials, data collection, regulatory submissions and funding for the process. |
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|
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● |
Enrolling
patients in clinical trials may be difficult for many reasons, including high screen failure, GD-T cell proliferation capacity, timing,
proximity and availability of clinical sites, perceived risks, and publicity about the success or lack of success in the methods
of treatment. |
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|
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● |
Because
GD-T cell therapies are novel, our research and development and clinical trial results may not support our products intended purposes
and regulatory approval. We are heavily dependent on the success of our lead product candidate (OmnImmune®), and intend to seek
breakthrough therapy designation for some or all of our other therapeutic candidates in due course. |
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● |
Market
opportunities for certain of our product candidates may be limited to those patients who are ineligible for or have failed prior
treatments. This class of patient may be limited in number, difficult to locate and service, require special governmental approval,
and unable to pay or obtain reimbursement. |
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● |
We
rely on many third parties for aspects of our product development and commercialization, such as raw material supply, clinical trials,
obtaining approvals, aspects of manufacturing, development of additional product candidates and distribution. We may not be able
to control these parties and their business practices, such as compliance with good manufacturing requirements or their ability to
supply or service us timely, which will likely disrupt our business. |
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|
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● |
We
face substantial competition: others may discover, develop and/or commercialize competing products before or more successfully than
TCB. |
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● |
Even
if we are able to commercialize any product candidates, such drugs may become subject to unfavorable pricing regulations or third-party
coverage and reimbursement policies. Commercialized products may not be adopted by the medical profession. |
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● |
Because
we operate internationally, we are subject to a wide array of regulation of the United Kingdom, European Union and United States.
In addition to regulation surrounding new drug development and their manufacture, distribution and use, we will be subject, for example
to data protection rules relating to medical records, medical and general privacy laws, environmental laws regarding medical waste,
and bribery and corrupt practices law, in addition to all the drug related approval, manufacturing and distribution rules. |
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● |
Product
liability claims are frequent in drug development of novel therapies and insurance is mandatory and expensive. The inability to obtain
insurance may prevent product development and claims may surpass our ability to pay and call into question the efficacy of a product
with resulting reputational damage. |
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|
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● |
Protecting
our intellectual property is paramount in our ability to be able to commercialize our products and generate revenues and investment
return for our stockholders. We may not be able to obtain the intellectual property protection we seek due to its cost, requirement
to pursue it in many jurisdictions, challenges by others and patent office rejection. |
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|
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● |
Obtaining
and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements
imposed by governmental patent agencies acting in multiple jurisdictions, and our patent protection could be reduced or eliminated
for non-compliance with these requirements. |
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|
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● |
As
part of product development, we may need to license aspects of our research and products from third parties or if our IP is challenged,
we may have to seek license accommodation, any of which may be expensive, limited in scope, or unavailable. |
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|
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● |
We
currently have a limited number of employees, and our future success depends on our ability to retain key executives and to attract,
retain and motivate qualified personnel at all levels. |
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● |
We
will need to grow the size and capabilities of our organization, and we may experience difficulties in managing this growth including,
but not limited to, operating as a public company and taking a therapeutic through to market approval and acceptance. |
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|
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● |
We
expect to expand our development and regulatory capabilities and potentially implement sales, marketing and distribution capabilities,
and as a result, we may encounter difficulties in achieving and managing our growth, which could disrupt our operations. We expect
to require further funding for these expansions of activity. |
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We
incur substantial costs as a result of operating as a public company in the United States, and our management is required to devote
substantial time to required SEC compliance and corporate governance practices. |
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If
we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis
could be impaired, which would adversely affect our business and our stock price. The Company identified a material weakness in
our internal control over accounting for complex financial instruments (including in determining the appropriate valuation basis
in areas requiring significant judgement) and in the accounting for our property leases on conversion from IFRS to GAAP. |
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● |
Certain
of our existing stockholders, members of our board of directors and senior management maintain the ability to exercise significant
control over us. The interests of investors may conflict with the interests of these other stockholders. |
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● |
Our
ADSs provide rights that are different from directly holding our ordinary shares. The outstanding Warrants do not have the rights
of shareholders until exercised. Our Warrants form a substantial part of our capitalization, and they have substantial protective
provisions, which may limit our ability to raise capital. |
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● |
Future
sales, or the possibility of future sales, of a substantial number of our ordinary shares, through the additional deposit of ordinary
shares for ADSs and exercises of our Warrants, could adversely affect the price of our ADSs or Warrants in the market. After any
lock up period, a substantial number of our issued and outstanding ordinary shares will be eligible for trading on the public securities
market by their being deposited with the depositary for ADSs. |
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● |
As a foreign private issuer, we, and our stockholders,
have certain exceptions to disclosure regulation under United States federal securities regulation, and we will take certain NASDAQ
governance exceptions. Consequently, investors may not have the totality of disclosure about and governance controls in TCB as compared
to United States domestic reporting companies. |
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Shareholder
rights and recourse will be governed by and ultimately determined by Scottish and United Kingdom law and judicial process, which
in many ways are more limited than United States law and practice. Half of our directors and officers are not resident in
the United States. Most of our assets are located in the United Kingdom. |
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● |
If
we fail to meet the requirements for continued listing on the Nasdaq Capital Market or Nasdaq, our ADSs could be delisted from trading,
which would decrease the liquidity of our ADSs and our ability to raise additional capital. On May 24, 2024, the Company received written
notification from the listing qualifications staff of the Nasdaq Stock Market, LLC indicating that the Company was not in compliance
with the Minimum Stockholders’ Equity Requirement, as of March 31, 2024. The Company requested and was granted a hearing
before a hearing panel on July 16, 2024 at which it requested continued listing on The Nasdaq Capital Market since it has returned
to compliance and expects to continue to do so. On August 1, 2024, the Company received written notification from Nasdaq that the
hearing panel granted the Company’s request to continue its listing on Nasdaq subject to compliance with the Minimum Stockholders’
Equity Requirement on or before August 15, 2024. There can be no assurance that the Company will timely evidence compliance with the
terms of any extension that may be granted by the Nasdaq following the hearing. Furthermore, the Company received a written
notification from the listing qualifications staff of the Nasdaq Stock Market, LLC. dated August 1, 2024 indicating that the minimum closing
bid price per share for its American Depositary Shares (the “ADSs”) was below $1.00 for a period of 30 consecutive business
days and that the Company did not meet the minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2) (the “Rule”).
Normally, a company would be afforded a 180-calendar day period to demonstrate compliance with the Rule. However, pursuant to Listing
Rule 5810(c)(3)(A)(iv), the Company is not eligible for any compliance period specified in Rule 5810(c)(3)(A) due to the fact that the
Company effected one or more reverse stock splits over the prior two-year period with a cumulative ratio of 250 shares or more to one.
Accordingly, this matter serves as an additional basis for delisting the Company’s securities from Nasdaq. Nasdaq informed the Company
that the hearing panel will consider this matter in their decision regarding the Company’s continued listing on Nasdaq. The Company
effected a change in the ratio of its ADSs to ordinary shares which had the effect to increase proportionally the ADS trading price, although
the Company can give no assurance that the ADS trading price after the ADS ratio change will be proportionally equal to or greater than
the previous’ ADS trading price prior to the change. There can be no assurance regarding the outcome of the hearing panel’s
determination with regard to this matter and the associated delisting notice. |
Risks
Related to this Offering and Ownership of ADSs
The
price of the ADSs has been, and is likely to continue to be, highly volatile, which could result in substantial losses for purchases
of ADSs in this offering.
The
price of the ADSs has been, and is likely to continue to be, highly volatile. The stock market in general and the market for smaller
pharmaceutical and biotechnology companies in particular have experienced extreme volatility that has often been unrelated to the operating
performance of particular companies. As a result of this volatility, purchasers of securities sold pursuant to this registration statement
may not be able to sell their ADSs at or above the price paid by such purchasers and, as such, they may lose some or all of their investment.
Additionally, in the past, securities class action litigation has often been brought against a company following a decline in the market
price of its securities. This risk is especially relevant for us in light of the significant stock price volatility we and other pharmaceutical
companies have experienced in recent years. If we face such litigation, it could result in substantial costs and a diversion of management’s
attention and resources, which could harm our business.
We
have broad discretion in the use of the net proceeds from this offering and any exercise of the Warrants and consequently may not use
them effectively.
Our
management will have broad discretion in the application of the net proceeds from this offering and any exercise of any Warrant and could
spend any such proceeds in ways that do not improve our results of operations or enhance the value of our ADSs. The failure by our management
to apply these funds effectively could result in financial losses that could cause the price of our ADSs to decline and delay the development
of our product candidates.
If
we fail to meet the requirements for continued listing on the Nasdaq Capital Market or Nasdaq, our ADSs could be delisted from
trading, which would decrease the liquidity of our ADSs and our ability to raise additional capital.
Our
ADSs are currently listed for quotation on The Nasdaq Capital Market. We are required to meet specified financial requirements in order
to maintain our listing on the Nasdaq Capital Market. These requirements include maintaining a minimum bid price of at least $1.00 per
share for our ADSs, which is referred to as the Bid Price Rule, and maintaining a minimum market value of listed securities, or the MVLS,
of $35,000,000. On July 12 and 15, 2022, we received deficiency letters from the Listings Qualifications Department of the Nasdaq Stock
Market notifying that we were not in compliance with the Bid Price Rule and the MVLS, respectively.
On
December 6, 2022, we received written notification from the listing qualifications staff of the Nasdaq Stock Market, LLC (“Nasdaq”)
indicating that the Company regained compliance with the Bid Price Rule. On January 12, 2023, we received written notification from the
listing qualifications staff of the Nasdaq indicating that we have not regained compliance with the MVLS and that our securities would
be subject to delisting unless we timely request a hearing before a Nasdaq Hearings Panel (the “Panel”). On March 9, 2023
the Company presented a formal plan to regain compliance to the Panel. On March 17, 2023, the Company announced that the TC BioPharm
(Holdings) plc has been granted a formal extension until June 30, 2023, to regain compliance under Nasdaq Listing Rule 5550(b)(2) or
its alternative criteria. The Company informed the Panel of its intention to regain compliance with Nasdaq’s continued listing
requirements by demonstrating compliance with the $2.5m minimum stockholders’ equity requirement in Listing Rule 5550(b)(1) as
an alternative to demonstrating compliance with the MVLS Requirement, the Panel granted the Company an exception until June 30, 2023.
On July 27, 2023, the Company received a letter, dated July 26, 2023 (the “Letter”) from Nasdaq notifying the Company that
the Panel has concluded that the Company has regained compliance with Nasdaq’s continued listing requirements. The Letter stated
that, pursuant to Listing Rule 5815(d)(4)(A), the Company will be subject to a Panel Monitor for a period of one year from the date of
the Letter. If, within that one-year monitoring period, the Listing Qualifications staff (the “Staff”) finds the Company
again out of compliance with any continued listing requirement, notwithstanding Rule 5810(c)(2), the Company will not be permitted to
provide the Staff with a plan of compliance with respect to any deficiency and the Staff will not be permitted to grant additional time
for the Company to regain compliance with respect to any deficiency, nor will the Company be afforded an applicable cure or compliance
period. Instead, the Staff will issue a Delist Determination Letter and the Company will have an opportunity to request a new hearing
with the initial Panel or a newly convened Hearings Panel if the initial Panel is unavailable.
On
June 22, 2023, we received a deficiency letter from the Staff notifying that we again were not in compliance with the Bid Price Rule.
We have been provided an initial period of 180 calendar days, or until December 19, 2023, to regain compliance with the applicable listing
requirement. On December 28, 2023, we received a letter from Nasdaq indicating that it has not regained compliance with the rule and
we were not eligible for a second 180 day period. On January 2, 2024, we received written confirmation from Nasdaq that it has determined
that for the last 10 consecutive business days, from December 15, 2023 to December 29, 2023, the closing bid price of the Company’s
securities has been at $1.00 per share or greater. Accordingly, the Company has regained compliance with Listing Rule 5550(a)(2) and
the matter is now closed.
As
previously reported in a Current Report on Form 8-K filed with SEC on May 20, 2024 (the “May 20 8-K’), on May 15, 2024, the
Company filed its Form 10-Q for the quarter ended March 31, 2024 (the “Form 10-Q”). As noted in the Form 10-Q, the Company
was not in compliance with the minimum stockholders’ equity requirement under Nasdaq Listing Rule 5550(b)(1) for continued listing
on The Nasdaq Capital Market because its stockholders’ equity was below the required minimum of $2.5 million (the “Minimum
Stockholders’ Equity Requirement”) at March 31, 2024. As previously reported in a Current Report on Form 8-K filed with the
SEC on May 8, 2024, on May 6, 2024, the Company entered into a letter agreement (the “Inducement Letter”) with certain holders
(the “Holders”) of existing Series E warrants (the “Existing Warrants”) to purchase ordinary shares represented
by ADSs of the Company. Pursuant to the Inducement Letter, the Holders agreed to exercise for cash their Existing Warrants to purchase
an aggregate of 175,000 ADSs of the Company for cash and the payment of £0.99625 (US$1.25) per new warrant in consideration
for the Company’s agreement to issue new Series F warrants to purchase ordinary shares represented by ADSs (the “New Warrants”)
to purchase up to 70,000,000 of the Company’s ordinary shares represented by 350,000 ADSs (the “New Warrant ADSs”).
On May 8, 2024, the Company received aggregate gross proceeds of approximately £3.1 million (approx. $3.9m) from the exercise
of the Existing Warrants by the Holders, prior to deducting placement agent fees and estimated offering expenses. As a result, the Company
believes that due to the exercise of the Existing Warrants it is now in compliance with the Minimum Stockholders’ Equity Requirement.
On
May 24, 2024, the Company received written notification from the listing qualifications staff of the Nasdaq indicating that the Company
was not in compliance with the Minimum Stockholders’ Equity Requirement, as of March 31, 2024. This letter indicated that while
Nasdaq estimates the Company is currently in compliance with the Minimum Stockholders’ Equity Requirement it notes that based on
the historical burn rate, without a significant transaction, the Company will not be in compliance as of the next period ending June
30, 2024.
Since
the Company was previously granted an exception to the Minimum Stockholders Equity Requirement by a Nasdaq Hearings Panel and subsequently
regained compliance, it is subject to a Mandatory Panel Monitor in accordance with Nasdaq Listing Rule 5815(d)(4)(A).
The Company requested
and was granted a hearing before a hearing panel on July 16, 2024 at which it requested continued listing on The Nasdaq Capital Market
since it has returned to compliance and expects to continue to do so. On August 1, 2024, the Company received written notification from
Nasdaq that the hearing panel granted the Company’s request to continue its listing on Nasdaq subject to compliance with the Minimum
Stockholders’ Equity Requirement on or before August 15, 2024. There can be no assurance that the Company will timely evidence
compliance with the terms of any extension that may be granted by the Nasdaq following the hearing.
The Company has
received a written notification from the listing qualifications staff of the Nasdaq Stock Market, LLC. dated August 1, 2024 indicating
that the minimum closing bid price per share for its American Depositary Shares (the “ADSs”) was below $1.00 for a period
of 30 consecutive business days and that the Company did not meet the minimum bid price requirement set forth in Nasdaq Listing Rule
5550(a)(2) (the “Rule”). Normally, a company would be afforded a 180-calendar day period to demonstrate compliance with the
Rule. However, pursuant to Listing Rule 5810(c)(3)(A)(iv), the Company is not eligible for any compliance period specified in Rule 5810(c)(3)(A)
due to the fact that the Company effected one or more reverse stock splits over the prior two-year period with a cumulative ratio of
250 shares or more to one. Accordingly, this matter serves as an additional basis for delisting the Company’s securities from Nasdaq.
Nasdaq informed the Company that the hearing panel will consider this matter in their decision regarding the Company’s continued
listing on Nasdaq. As detailed below, the Company effected a change in the ratio of its ADSs to ordinary shares which had the effect
to increase proportionally the ADS trading price, although the Company can give no assurance that the ADS trading price after the ADS
ratio change will be proportionally equal to or greater than the previous’ ADS trading price prior to the change. There can be no assurance regarding the outcome of the hearing panel’s determination with regard to this matter
and the associated delisting notice.
The
Company continues to execute its business plan and is looking into various options available to regain compliance with Nasdaq’s
continued listing standards and maintain its continued listing on the Nasdaq Capital Market. However, there can be no assurance that
the Company will be able to maintain compliance with the Nasdaq listing rules. In addition, there can be no assurance that the Panel
will determine to continue the Company’s listing on The Nasdaq Capital Market following the hearing.
The
exercise of outstanding ADS purchase warrants and share options will have a dilutive effect on the percentage ownership of our capital
stock by existing stockholders.
As
of August 12, 2024, we had outstanding warrants to acquire 383,817 ADSs, and share options to purchase 18,420,538 shares of our
ordinary shares. A significant number of such warrants have exercise prices above our ADSs’ recent trading prices, but the holders
have the right, in certain circumstances, to effect a cashless exercise of such warrants. If a significant number of such warrants and
share options are exercised by the holders, the percentage of our ADSs owned by our existing ADS holders will be diluted.
There
is no public market for Warrants or pre-funded warrants being offered by us in this offering.
There
is no established public trading market for the Warrants or pre-funded warrants, and we do not expect a market to develop. In addition,
we do not intend to apply to list the Warrants or pre-funded warrants on any national securities exchange or other nationally recognized
trading system. Without an active market, the liquidity of the Warrants or pre-funded warrants will be limited.
The
Warrants and pre-funded warrants are speculative in nature.
The
Warrants and pre-funded warrants offered hereby do not confer any rights of ADS ownership on their holders, such as voting rights, but
rather merely represent the right to acquire shares of ADS at a fixed price. Specifically, holders of the pre-funded warrants may acquire
the ADSs issuable upon exercise of such warrants at an exercise price of $0.001 per ADS, and holders of the pre-funded warrants may acquire
the ADSs issuable upon exercise of such warrants at an exercise price of £0.78 per ADS. The Series G warrants will expire
on the first anniversary of the initial issuance date. Moreover, following this offering, the market value of the Warrants and pre-funded
warrants is uncertain and there can be no assurance that the market value of the Warrants and pre-funded warrants will equal or exceed
their public offering prices. There can be no assurance that the market price of the ADSs will ever equal or exceed the exercise price
of the Warrants and pre-funded warrants, and consequently, whether it will ever be profitable to exercise the Warrants and pre-funded
warrants.
Holders
of the Warrants and pre-funded warrants offered hereby will have no rights as ADS holders with respect to the ADSs underlying the Warrants
or pre-funded warrants until such holders exercise their Warrants or pre-funded warrants and acquire our ADSs, except as otherwise provided
in the Warrants or pre-funded warrants.
Until
holders of the Warrants and pre-funded warrants acquire ADSs upon exercise thereof, such holders will have no rights with respect to
the ADSs underlying such Warrants or pre-funded warrants, except to the extent that certain rights may be granted to warrant holders
as set forth in the Warrants and pre-warrants. Upon exercise of the Warrants or pre-funded warrants, the holders will be entitled to
exercise the rights of an ADS holder only as to matters for which the record date occurs after the exercise date.
This
is a best efforts offering, no minimum amount of securities is required to be sold, and we may not raise the amount of capital we believe
is required for our business plans, including our near-term business plans.
There is no required minimum number of securities that must be sold as a condition to completion of this offering.
Because there is no minimum offering amount required as a condition to the closing of this offering, the actual offering amount and proceeds to us are not presently determinable and may be substantially less than the maximum amount set forth above.
We may sell fewer than all of the securities offered hereby, which may significantly reduce the amount of proceeds received by us, and
investors in this offering will not receive a refund in the event that we do not sell an amount of securities sufficient to support our
continued operations, including our near-term continued operations. Thus, we may not raise the amount of capital we believe is required
for our operations in the short-term and may need to raise additional funds, which may not be available or available on terms acceptable
to us.
You
may experience immediate dilution in the book value per ADS purchased in the offering.
Because
the price per share of our ADSs being offered may be higher than the net tangible book value per ADS, you will experience dilution to
the extent of the difference between the offering price per ADS you pay in this offering and the net tangible book value per ADS immediately
after this offering. Our net tangible book value as of March 31, 2024, was approximately $0.6 million, or $1.87 per ADS. Net tangible
book value per ADS is equal to our total tangible assets minus total liabilities, all divided by the number of ADSs outstanding. See
the section titled “Dilution” for a more detailed discussion of the dilution you will incur if you purchase shares in this
offering.
If
you purchase our securities in this offering you may experience future dilution as a result of future equity offerings or other equity
issuances.
In
order to raise additional capital, we believe that we will offer and issue additional ADSs or other securities convertible into or exchangeable
for our ADSs in the future. We cannot assure you that we will be able to sell ADSs or other securities in any other offering at a price
per ADS that is equal to or greater than the price per ADS paid by investors in this offering, and investors purchasing other securities
in the future could have rights superior to existing stockholders. The price per ADS at which we sell additional ADSs or other securities
convertible into or exchangeable for our ADSs in future transactions may be higher or lower than the price per ADS in this offering.
In
addition, we have a significant number of share options and warrants outstanding. To the extent that outstanding share options or warrants
have been or may be exercised or other shares issued, you may experience further dilution. Further, we may choose to raise additional
capital due to market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating
plans.
The
exercise of outstanding ADS purchase warrants and share options will have a dilutive effect on the percentage ownership of our capital
stock by existing stockholders.
As
of August 12, 2024, we had outstanding warrants to acquire 383,817 ADSs, and share options to purchase 18,420,538 of our ordinary
shares. A significant number of such warrants have exercise prices above our ADSs’ recent trading prices, but the holders have
the right, in certain circumstances, to effect a cashless exercise of such warrants. If a significant number of such warrants and share
options are exercised by the holders, the percentage of our ADSs owned by our existing ADS holders will be diluted.
We
face risks and uncertainties related to litigation, regulatory actions and government investigations and inquiries.
We
are subject to, and may become a party to, litigation, claims, suits, regulatory actions and government investigations and inquiries.
The
outcome of any litigation, regardless of its merits, is inherently uncertain. Any claims and lawsuits, and the disposition of such
claims and lawsuits, could be time-consuming and expensive to resolve, divert management attention and resources, and lead to attempts
on the part of other parties to pursue similar claims. Negative perceptions of our business may result in additional regulation, enforcement
actions by the government and increased litigation, or harm to our ability to attract or retain customers or strategic partners,
any of which may affect our business. Any damage to our reputation, including from publicity from legal proceedings against us or companies
that work within our industry, governmental proceedings, unfavorable media coverage or class action could adversely affect our business,
financial condition and results of operations.
An
unfavorable outcome or settlement or any other legal, administrative and regulatory proceeding may result in a material adverse impact
on our business, results of operations, financial position and overall trends. In addition, regardless of the outcome, litigation can
be costly, time-consuming, and disruptive to our operations. Any claims or litigation, even if fully indemnified or insured, could
damage our reputation and make it more difficult to compete effectively or to obtain adequate insurance in the future.
In
accordance with the terms of a Convertible Loan Note (the “Note”) on August 9, 2022 (the “Conversion Date”) the
Company issued 183,820 Ordinary Shares and 36,764 listed warrants to the Note holder in full satisfaction of the Note in the aggregate
amount of $781,233. The holder filed a claim in the English courts on June 19, 2023 asserting that notice was provided such that the
Company should have paid it the value of the Note in cash, rather than by settling it through the issuance of Ordinary Shares and listed
warrants. The holder is demanding payment of the face value of the Note, together with interest, (approximately $860,000). The litigation
process is in its early stages and is not expected to conclude until 2025 or later. The Company is contesting the claim in its entirety
and believes that it acted correctly, under the terms of the Note and has accounted for the transaction on that basis, and that no further
amounts are payable to the holder.
If
we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could
be impaired, which would adversely affect our business and our stock price.
Ensuring
that we have adequate internal financial and accounting controls and procedures in place to produce accurate financial statements on
a timely basis is a costly and time-consuming effort that needs to be re-evaluated frequently. We may discover material weaknesses in
our internal financial and accounting controls and procedures that need improvement from time to time.
Management
is responsible for establishing and maintaining adequate internal control over financial reporting to provide reasonable assurance regarding
the reliability of our financial reporting and the preparation of financial statements for external purposes. Management does not expect
that our internal control over financial reporting will prevent or detect all errors and all fraud. A control system, no matter how well
designed and operated, can provide only reasonable, not absolute, assurance that the control system’s objectives will be met. Because
of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that misstatements due to
error or fraud will not occur or that all control issues and instances of fraud, if any, within our company will have been detected.
Pursuant
to Section 404 of the Sarbanes-Oxley Act of 2002, or Section 404, we are required to furnish a report by our senior management on our
internal control over financial reporting, commencing with our second annual report. However, while we remain an EGC we are not required
to include an attestation report on internal control over financial reporting issued by our independent registered public accounting
firm. To prepare for eventual compliance with Section 404, once we no longer qualify as an EGC, we are engaged in a process to document
and evaluate our internal control over financial reporting, which is both costly and challenging. In this regard, we will need to continue
to dedicate internal resources, potentially engage outside consultants, adopt a detailed work plan to assess and document the adequacy
of internal control over financial reporting, continue steps to improve control processes as appropriate, validate through testing that
controls are functioning as documented, and implement a continuous reporting and improvement process for internal control over financial
reporting. Despite our efforts, there is a risk that we will not be able to conclude, within the prescribed timeframe or at all, that
our internal control over financial reporting is effective as required by Section 404. If we identify one or more material weaknesses,
it could result in an adverse reaction in the financial markets due to a loss of confidence in the reliability of our financial statements.
In addition, if we are unable to produce accurate financial statements on a timely basis, investors could lose confidence in the reliability
of our financial statements, which could cause the market price of either of our ADSs or Warrants, or both, to decline and make it more
difficult for us to finance our operations and growth.
The
Company notes that the auditors identified that the Company experienced difficulty in the accounting for complex financial instruments
and leases, and the Company lacked adequate internal control over the accounting and assessment of complex financial instruments following
control deficiencies which they believed constituted a material weakness in the Company’s internal control over financial reporting
as of December 31, 2023. The Company recognizes this error as a material weakness and has established controls to support assessment
and review of accounting for complex financial instruments and leases.
Purchasers
who purchase our securities in this offering pursuant to a securities purchase agreement may have rights not available to purchasers
that purchase without the benefit of a securities purchase agreement.
In
addition to rights and remedies available to all purchasers in this offering under federal securities and state law, the purchasers that
enter into a securities purchase agreement will also be able to bring claims of breach of contract against us. The ability to pursue
a claim for breach of contract provides those investors with the means to enforce the covenants uniquely available to them under the
securities purchase agreement including: (i) timely delivery of shares; (ii) agreement to not enter into variable rate financings for
one year from closing, subject to certain exceptions; (iii) agreement to not issue any ordinary shares or ADSs or securities convertible
into ordinary shares or ADSs for ninety (90) days from closing, subject to certain exceptions; and (iv) indemnification for breach
of contract.
Unstable
market and economic factors could adversely affect our business, financial condition or results of operations.
Uncertain
or unfavorable global economic or market conditions, such as a recession, an economic slowdown, inflation or reduced growth rates, could
significantly impact our operating results or lead to significant reductions in funding sources available to the Company, which could
adversely affect our business, results of operations or financial condition. Our operations have required substantial amounts of cash
since inception. We expect to continue to spend substantial amounts to continue the development of our GD-T cell-based therapeutic candidates,
including for future clinical trials. In the event of unstable markets and unfavorable market conditions, we cannot be certain that additional
funding will be available on acceptable terms, or at all. We have no committed source of additional capital. If we are unable to raise
additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue
the development or commercialization of our GD-T cell-based therapeutic candidates or other research and development initiatives. Furthermore,
uncertain or unfavorable global economic or market conditions may cause our manufacturers, suppliers, distributors, contractors, logistics
providers and other external business partners to suffer financial or operational difficulties, which could impact their ability to provide
us with or distribute finished product, raw and packaging materials or services in a timely manner or at all. We could also face difficulty
collecting or recovering accounts receivables from third parties facing financial or operational difficulties.
DIVIDEND
POLICY
Since
inception, we have not declared or paid any dividends on our ordinary shares. We do not have any current plans to pay any dividends on
our ordinary shares, including those represented by ADSs, in the foreseeable future. We intend to retain all our available funds and
any future earnings to operate and expand our business. Because we do not anticipate paying any cash dividends in the foreseeable future.
Capital appreciation, if any, will be your sole source of gains, and you may never receive a return on your investment.
The
determination to pay dividends, if any, will be made at the discretion of our board of directors and may be based on a number of factors,
including our future operations and earnings, capital requirements and surplus, general financial condition, contractual and legal restrictions
and other factors that the board of directors may deem relevant.
Under
current Scottish law, among other things, a company’s accumulated realized profits must exceed its accumulated realized losses
(on a non-consolidated basis) before dividends can be paid. Accordingly, we may only pay dividends if we have sufficient distributable
reserves (on a non-consolidated basis), which are our accumulated realized profits that have not been previously distributed or capitalized
less our accumulated realized losses, so far as such losses have not been previously written off in a reduction or reorganization of
capital.
USE
OF PROCEEDS
We
estimate that our gross proceeds from this offering will be approximately $2 million, before deducting estimated offering expenses of
approximately $0.2 million (based on an assumed public offering price per ADS of $1.00 per ADS and accompanying warrants,). However, because this is a best efforts
offering and there is no minimum offering amount required as a condition to the closing of this offering, the actual offering amount,
and net proceeds to us are not presently determinable and may be substantially less than the maximum amounts set forth on the cover page
of this prospectus.
If
all of the Warrants to purchase ADSs issued in connection with this offering are fully exercised for cash, we would receive additional
aggregate proceeds of approximately $2 million.
We
intend to use the net proceeds of this offering to support our upcoming clinical trial focusing on relapse/refractory Acute Myeloid Leukemia
(AML), and for continuing operating expenses and working capital.
With
existing resources and the net proceeds received as a result of this offering (approximately $1.8 million, after deducting estimated
offering expenses of approximately $0.2 million (based on an assumed public offering price per ADS of $1.00 per ADS and accompanying
warrant), based on an assumed
offering with aggregate net proceeds of $1.8 million, we expect to be able to fund current operations to September 2024, through the
period in which the Company will be preparing to initiate patient dosing in our upcoming clinical trials. The reaching of this value
inflection point is reasonably expected to provide support for additional funding initiatives. In a scenario where the net proceeds are
lower than $1.8 million, the Company would manage working capital such that the cash runway would be adjusted to reflect the lower net
proceeds.
As
described in our 2023 10-K and in common with many clinical development stage biotechnology companies our future liquidity needs, and
ability to address them, will largely be determined by the availability of capital, both generally and in particular to fund our product
candidates and key development and regulatory projects. As a pre-revenue biotechnology company, we have financed our operations though
continuously raising capital; and we expect to continue having to raise capital routinely on the capital markets, taking advantage of
our public listing. We are constantly formulating and implementing potential funding initiatives to ensure we have adequate working capital. These initiatives could be in the form of further equity raises, as noted earlier and/or non-dilutive financings arising from collaborations
or licensing arrangements.
The
amounts and timing of our actual expenditures will depend on numerous factors, including the progress of our clinical trials, the potential
for achieving accelerated regulatory approval and the amount of cash used in our operations. We therefore cannot estimate with certainty
the amount of net proceeds to be used for the purposes described above. We may find it necessary or advisable to use the net proceeds
for other purposes, and we will have broad discretion in the application of the net proceeds. Our shareholders may not agree with the
manner in which our management chooses to allocate and spend the net proceeds. Moreover, our management may use the net proceeds for
corporate purposes that may not result in our being profitable or increase our market value.
Pending
these uses, we plan to invest these net proceeds in short-term, interest-bearing obligations; investment-grade instruments; certificates
of deposit; or direct or guaranteed obligations of the United States and the United Kingdom. The goal with respect to the investment
of these net proceeds is capital preservation and liquidity so that such funds are readily available to fund our operations. Our investment
positions will also take into consideration the law and rules under the U.S. Investment Company Act of 1940, so as to avoid being characterized
as an investment company thereunder.
CAPITALIZATION
You
should read this information together with our Form 10-Q for the period ended March 31, 2024 and related notes of TC BioPharm
(Holdings) plc included in our March 31, 2024 Form 10-Q and incorporated by reference in this prospectus and the information
set forth under the sections titled “Use of Proceeds” and “Item 1. “Financial Statements” included in our most recent Form 10-Q incorporated by reference.
The
following table sets forth our cash and cash equivalents, indebtedness and capitalization as of March 31, 2024, on:
(1)
a pro forma basis to give effect to the Series E warrant inducement that occurred on May 8, 2024 .
(2)
a pro forma basis as adjusted to give effect to the sale of 23,950 ADSs and 1,976,050 pre-funded Warrants for 1,976,050 ADSs
(which for the purposes of the table below are assumed to have been exercised in full) and 2,000,000 Series G Warrants at a public offering price of $1.00 per ADS and warrant in this offering and after deducting the estimated
offering expenses payable by us.
The
pro forma as adjusted calculations assume a public offering price of $1.00 per one ADS after deducting the estimated offering
expenses payable by us.
| |
|
As
of March 31, 2024 |
|
| |
|
Actual
(1) |
|
|
Pro
Forma (2) |
|
|
Pro
Forma As Adjusted(b) (3) |
|
| |
|
(in
thousands, except share and per share data) |
|
| |
|
£ |
|
|
$
|
|
|
$ |
|
|
$ |
|
| Cash
and cash equivalents |
|
|
981 |
|
|
|
1,239 |
|
|
|
4,703 |
|
|
|
6,498 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Warrant
liabilities (a) |
|
|
2 |
|
|
|
3 |
|
|
|
3 |
|
|
|
3 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Total
equity attributable to equity holders: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Ordinary
shares, 63,902,641 shares authorized, issued and outstanding, actual; £0.0001 par value 98,902,641 shares authorized, issued
and outstanding, pro forma; £0.0001 par value 498,902,641 shares authorized, issued and outstanding, pro forma as adjusted |
|
|
6 |
|
|
|
8 |
|
|
|
12 |
|
|
|
16 |
|
| Deferred
shares, £0.4999; 794,955 shares authorized, issued and outstanding, pro forma. |
|
|
397 |
|
|
|
501 |
|
|
|
501 |
|
|
|
501 |
|
| Additional
paid-in-capital |
|
|
42,836 |
|
|
|
54,085 |
|
|
|
57,545 |
|
|
|
59,336 |
|
| Accumulated
deficit |
|
|
(42,159 |
) |
|
|
(53,230 |
) |
|
|
(53,230 |
) |
|
|
(53,230 |
) |
| Total
shareholders’ equity |
|
|
1,080 |
|
|
|
1,364 |
|
|
|
4,828 |
|
|
|
6,623 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Total
capitalization |
|
|
1,082 |
|
|
|
1,367 |
|
|
|
4,831 |
|
|
|
6,626 |
|
| (a) |
Represents the fair value
as of March 31, 2024 of the Warrants to purchase up to 7,567 ADSs. |
The
number of our ordinary shares (including shares represented by ADSs) to be outstanding after this offering is based on 98,902,641 ordinary
shares outstanding as of August 12, 2024 and excludes:
| |
● |
106,585
ordinary shares issuable upon the exercise of options outstanding under our 2014 Share Option Scheme as of March 31, 2024, with a
weighted-average exercise price of £23.00 per share; |
| |
|
|
| |
● |
20,202
ordinary shares issuable upon the exercise of options outstanding under our 2021 Share Option Scheme, as of March 31, 2024, with
a weighted-average exercise price of $212.00 per share; |
| |
|
|
| |
● |
17,575,360
ordinary shares issuable upon the exercise of options outstanding under our 2021 Share Option Scheme, as of March 31, 2024, with
a weighted-average exercise price of $0.06 per share; |
| |
|
|
| |
● |
702,500
ordinary shares issuable upon the exercise of options outstanding under our 2021 Share Option Scheme, as of March 31, 2024, with
a weighted-average exercise price of $0.409 per share; |
| |
|
|
| |
● |
15,891
ordinary shares issuable upon the exercise of options outstanding, at a future date based on the achievement of certain clinical
and commercial milestones with an exercise price of £215.00 per share; and |
| |
|
|
| |
● |
76,763,300
ordinary shares issuable upon the exercise of warrants outstanding, as of August 12, 2024, with a weighted-average exercise
price of £0.184 per share. |
For
the description of the 2014 Share Option Scheme and 2021 Share Option Scheme please refer to the 2023 Form 10-K, which is incorporated
by reference herein.
Unless
otherwise stated, all information in this prospectus assumes no exercise of the outstanding options described above into ordinary shares
or ADSs, treats all restricted shares issued with outstanding restrictions to be vested as issued and outstanding shares, no exercise
of the Warrants issued in this offering and no sale of pre-funded warrants in this offering.
Except
as otherwise indicated all references to our articles of association in this prospectus refer to our articles of association, as amended
as currently in force for TC BioPharm (Holdings) plc at the date of this prospectus.
To
the extent these outstanding options or any newly issued options are exercised, or we issue additional ordinary shares in the future,
there will be further dilution to the new investors purchasing ordinary shares represented by ADSs in this offering. In addition, we
may choose to raise additional capital because of market conditions or strategic considerations, even if we believe that we have sufficient
funds for our current or future operating plans. If we raise additional capital through the sale of equity or convertible debt securities,
the issuance of these securities could result in further dilution to our shareholders.
DILUTION
If
you invest in our ADSs in this offering, your ownership interest of our ordinary shares will be diluted to the extent there
is a difference between the public offering price per ADS in this offering and the pro forma as adjusted net tangible book value
per ADS after this offering. For the purposes of calculating the potential impact of dilution, the full value of an assumed offering
price of $1.00 per ADS and warrant has been ascribed to the ADSs. Dilution results from the fact that the public offering price
per ADS is substantially in excess of the net tangible book value per ADS.
As
of March 31, 2024, we had a historical net tangible book value of $0.6 million (equivalent to £0.5 million), or $1.87 per
ADS (equivalent to £1.48 per ADS). Our net tangible book value per ADS represents total tangible assets less total liabilities,
divided by the number of ordinary shares outstanding on March 31, 2024.
After
giving further effect to 1) the inducement of the Series E warrants on May 8, 2024 which resulted in the issuance of 175,000 ADSs and
2) sale of 23,950 ADSs and 1,976,050 pre-funded Warrants for 1,976,050 ADSs (which for the purposes of the table below are assumed
to have been exercised in full) and 2,000,000 Series G Warrants at a public offering price of $1.00 per ADS and warrant The following
table illustrates this dilution to new investors purchasing ADSs in this offering:
| Assumed public offering price per ADS | |
| | | |
$ | 1.00 | |
| Historical net tangible book value per ADS as at March 31, 2024. | |
$ | 1.87 | | |
| | |
| Increase in net tangible book value per ADS attributable to transactions in the period to August 7, 2024, as described above. | |
| 6.34 | | |
| | |
| Pro forma net tangible book value per ADS as of March 31, 2024. | |
| 8.21 | | |
| | |
| Decrease in net tangible book value per ADS attributable to this offering | |
| (5.86 | ) | |
| | |
| Pro forma as adjusted net tangible book value per ADS after this offering(1) | |
| | | |
| 2.35 | |
| Dilution (anti-dilution) per ADS to new investors purchasing ADSs in this
offering | |
| | | |
$ | (1.35 | ) |
The
number of our ordinary shares (including shares represented by ADSs) to be outstanding after this offering is based on 98,902,641 ordinary
shares outstanding as of August 7, 2024 and excludes:
| |
● |
106,585
ordinary shares issuable upon the exercise of options outstanding under our 2014 Share Option Scheme as of March 31, 2024, with a
weighted-average exercise price of £23.00 per share; |
| |
|
|
| |
● |
20,202
ordinary shares issuable upon the exercise of options outstanding under our 2021 Share Option Scheme, as of March 31, 2024, with
a weighted-average exercise price of $212.00 per share; |
| |
|
|
| |
● |
17,575,360
ordinary shares issuable upon the exercise of options outstanding under our 2021 Share Option Scheme, as of March 31, 2024, with
a weighted-average exercise price of $0.06 per share; |
| |
|
|
| |
● |
702,500
ordinary shares issuable upon the exercise of options outstanding under our 2021 Share Option Scheme, as of March 31, 2024, with
a weighted-average exercise price of $0.409 per share; |
| |
|
|
| |
● |
15,891
ordinary shares issuable upon the exercise of options outstanding, at a future date based on the achievement of certain clinical
and commercial milestones with an exercise price of £215.00 per share; and |
| |
|
|
| |
● |
76,763,300
ordinary shares issuable upon the exercise of warrants outstanding, as of August 12, 2024, with a weighted-average exercise
price of £0.184 per share. |
Unless
otherwise stated, all information in this prospectus assumes no exercise of the outstanding options described above into ordinary shares
or ADSs, treats all restricted shares issued with outstanding restrictions to be vested as issued and outstanding shares, no exercise
of the Warrants issued in this offering and no sale of pre-funded warrants in this offering.
MATERIAL
INCOME TAX CONSIDERATIONS
The
following summary contains a description of material U.K. and U.S. federal income tax consequences of the acquisition, ownership and
disposition of our ordinary shares. This summary should not be considered a comprehensive description of all the tax considerations that
may be relevant to the decision to acquire our ordinary shares.
U.S.
Federal Income Taxes
The
following is a summary of the material U.S. federal income tax consequences to U.S. Holders (as defined below) of purchasing, owing and
disposing of the ordinary shares or ADSs. This discussion is included for general informational purposes only, does not purport to consider
all aspects of U.S. federal income taxation that might be relevant to a U.S. Holder, and does not constitute, and is not, a tax opinion
for or tax advice to any particular U.S. Holder of ordinary shares or the ADSs. The summary does not address any U.S. tax matters other
than those specifically discussed. The summary is based on the provisions of the U.S. Internal Revenue Code of 1986, as amended (the
“Code”), existing, temporary and proposed Treasury Regulations issued thereunder, judicial decisions and administrative
rulings and pronouncements and other legal authorities, all as of the date hereof and all of which are subject to change, possibly with
retroactive effect. Any such change could alter the tax consequences described herein.
The
discussion below applies only to U.S Holders as capital assets within the meaning of Section 1221 of the Code (generally, property held
for investment), and does not address the tax consequences that may be relevant to U.S. Holders who, in light of their particular circumstances,
may be subject to special tax rules, including without limitation:
| ● |
insurance
companies, tax-exempt organizations, regulated investment companies, real estate investment trusts, brokers or dealers in securities
or foreign currencies, banks and other financial institutions, mutual funds, retirement plans, traders in securities that elect to
mark to market, certain former U.S. citizens or long-term residents; |
| |
|
| ● |
U.S.
Holders that are classified for U.S. federal income tax purposes as partnerships and other pass-through entities and investors therein; |
| |
|
| ● |
U.S.
Holders who hold ordinary shares or ADSs as part of a hedge, straddle, constructive sale, conversion, or other integrated or risk-reduction
transaction, as “qualified small business stock,” within the meaning of Section 1202 of the Code or as Section 1244 stock
for purposes of the Code; |
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U.S.
Holders who hold ordinary shares or ADSs through individual retirement or other tax-deferred accounts; |
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U.S.
Holders that have a functional currency other than the U.S. dollar; |
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U.S.
Holders who are subject to the alternative minimum tax provisions of the Code or the Medicare surtax of 3.8% on net investment income
imposed by Section 1411 of the Code; |
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U.S.
Holders who acquire their ordinary shares or ADSs pursuant to any employee share option or otherwise as compensation; |
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U.S.
Holders required to accelerate the recognition of any item of gross income with respect to their ordinary shares or ADSs as a result
of such income being recognized on an applicable financial statement; or |
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U.S.
Holders who hold or held, directly or indirectly, or are treated as holding or having held under applicable constructive attribution
rules, 10% or more of the ordinary shares or ADSs of the company, measured by voting power or value. |
Any
such U.S. Holders should consult their own tax advisors.
For
purposes of this discussion, a “U.S. Holder” means a holder of our ordinary shares or ADSs that is or is treated as, for
U.S. federal income tax purposes,
| (i) |
an
individual citizen or resident of the United States; |
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| (ii) |
a
corporation (or other entity taxable as a corporation for U.S. federal income tax purposes) created or organized in or under the
laws of the United States, any State thereof or the District of Columbia or any entity treated as such for U.S. federal income tax
purposes; |
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| (iii) |
an
estate the income of which is subject to U.S. federal income taxation regardless of its source, or |
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| (iv) |
a
trust (A) the administration over which a U.S. court exercises primary supervision and all of the substantial decisions of which
one or more U.S. persons have the authority to control, or (B) that has a valid election in effect under the applicable Treasury
Regulations to be treated as a U.S. person under the Code. |
If
a partnership or other pass-through entity (including any entity or arrangement treated as such for purposes of U.S. federal income tax
law) holds our ordinary shares or ADSs, the tax treatment of a partner of such partnership or member of such entity will generally depend
upon the status of the partner and the activities of the partnership. Partnerships and other pass-through entities holding our ordinary
shares or ADSs, and any person who is a partner or member of such entities should consult their own tax advisors regarding the tax consequences
of purchasing, owning and disposing of the ordinary shares or ADSs.
Passive
Foreign Investment Company Considerations
A
non-U.S. corporation, such as TCB, will be classified as a passive foreign investment company, or PFIC, for U.S. federal income tax purposes,
if, in the case of any particular taxable year, either (i) 75% or more of its gross income for such taxable year consists of certain
types of “passive” income or (ii) 50% or more of the value of its assets (based on an average of the quarterly values of
the assets) during such taxable year is attributable to assets that produce or are held for the production of passive income. For this
purpose, cash is categorized as a passive asset and the company’s un-booked intangibles associated with active business activities
may generally be classified as active assets. Passive income generally includes, among other things, dividends, interest, rents, royalties,
and gains from the disposition of passive assets. For this purpose, a foreign corporation will be treated as owning its proportionate
share of the assets and earning its proportionate share of the income of any other non-U.S. corporation in which it owns, directly or
indirectly, more than 25% (by value) of the stock.
Based
upon its current income and assets and projections as to the value of the ordinary shares or ADSs, it is not presently expected that
we will be classified as a PFIC for the 2022 taxable year or the foreseeable future.
The
determination of whether we will be or become a PFIC will depend upon the composition of its income (which may differ from our historical
results and current projections) and assets and the value of its assets from time to time, including, in particular the value of its
goodwill and other un-booked intangibles (which may depend upon the market value of the ordinary shares or ADSs from time to time and
may be volatile). Among other matters, if our market capitalization is less than anticipated or subsequently declines, we may be classified
as a PFIC for the taxable year in the 2021 taxable year or future taxable years. It is also possible that the IRS may challenge the classification
or valuation of our assets, including its goodwill and other unbooked intangibles, or the classification of certain amounts received
by us, including interest earnings, which may result in our being, or becoming classified as, a PFIC for the taxable year in 2021 or
future taxable years.
The
determination of whether we will be or become a PFIC may also depend, in part, on how, and how quickly, it uses liquid assets and the
cash proceeds of this offering or otherwise. If we were to retain significant amounts of liquid assets, including cash, the risk of our
being classified as a PFIC may substantially increase. Because there are uncertainties in the application of the relevant rules and PFIC
status is a factual determination made annually after the close of each taxable year, there can be no assurance that we will not be a
PFIC for the 2022 taxable year or any future taxable year, and no opinion of counsel has or will be provided regarding the classification
of us as a PFIC. If we were classified as a PFIC for any year during which a holder held our ordinary shares or ADSs, it generally would
continue to be treated as a PFIC for all succeeding years during which such holder held the ordinary shares or ADSs. The discussion below
under “—Dividends Paid on Ordinary Shares or ADSs” and “—Sale or Other Disposition of Ordinary Shares or
ADS” is written on the basis that we will not be classified as a PFIC for U.S. federal income tax purposes.
Dividends
Paid on Ordinary Shares including ordinary shares represented by ADSs
Subject
to the PFIC rules described below, any cash distributions (including constructive distributions) paid on the ordinary shares including
ordinary shares represented by ADSs out of our current or accumulated earnings and profits, as determined under U.S. federal income tax
principles, will generally be includible in the gross income of a U.S. Holder as dividend income on the day actually or constructively
received by the U.S. Holder, in the case of ordinary shares including ordinary shares represented by ADSs. Because we do not intend to
determine our earnings and profits on the basis of U.S. federal income tax principles, any distribution will generally be treated as
a “dividend” for U.S. federal income tax purposes. Under current law, a non-corporate recipient of a dividend from a “qualified
foreign corporation” will generally be subject to tax on the dividend income at the lower applicable net capital gains rate rather
than the marginal tax rates generally applicable to ordinary income provided that certain holding period and other requirements are met.
A
non-U.S. corporation (other than a corporation that is classified as a PFIC for the taxable year in which the dividend is paid or the
preceding taxable year) will generally be considered to be a qualified foreign corporation (i) if it is eligible for the benefits of
a comprehensive tax treaty with the United States which the Secretary of Treasury of the United States determines is satisfactory for
these purposes and which includes an exchange of information program, or (ii) with respect to any dividend paid by such corporation on
its stock, if such stock is readily tradable on an established securities market in the United States. We believe we are eligible for
the benefits of the Convention Between the Government of the United States of America and the Government of the United Kingdom of Great
Britain and Northern Ireland for the Avoidance of Double Taxation and the Prevention of Fiscal Evasion with Respect to Taxes on Income
and On Capital Gains, or the United States-United Kingdom income tax treaty (which the Secretary of the Treasury of the United States
has determined is satisfactory for this purpose and includes an exchange of information program), in which case it would be treated as
a qualified foreign corporation with respect to dividends paid on the ordinary shares or ADSs. U.S. Holders are urged to consult their
tax advisors regarding the availability of the reduced tax rate on dividends in their particular circumstances. Dividends received on
the ordinary shares will not be eligible for the dividends received deduction allowed to corporations.
Sale
or Other Disposition of Ordinary Shares or ADSs
Subject
to the PFIC rules discussed below, a U.S. Holder of our ordinary shares or ADSs will generally recognize capital gain or loss, if any,
upon the sale or other disposition of ordinary shares or ADSs, respectively, in an amount equal to the difference between the amount
realized upon the disposition and the U.S. Holder’s adjusted tax basis in such ordinary shares or ADSs. Any capital gain or loss
will be long-term capital gain or loss if the ordinary shares or ADSs have been held for more than one year and will generally be United
States source capital gain or loss for United States foreign tax credit purposes. Long-term capital gains of non-corporate taxpayers
are currently eligible for reduced rates of taxation.
Disposition
of Foreign Currency
U.S.
Holders are urged to consult their tax advisors regarding the tax consequences of receiving, converting or disposing of any non-U.S.
currency received as dividends on our ordinary shares or ADSs.
Tax
on Net Investment Income
A
U.S. Holder may be subject to a Medicare surtax of 3.8% on some or all of such U.S. Holder’s “net investment income”
as defined in Section 1411 of the Code. Net investment income generally includes income from the ordinary shares or ADSs unless such
income is derived in the ordinary course of the conduct of a trade or business (other than a trade or business that consists of certain
passive or trading activities). You should consult your tax advisors regarding the effect this Medicare tax may have, if any, on your
acquisition, ownership or disposition of ordinary shares or ADSs.
Passive
Foreign Investment Company Rules
If
we are is classified as a PFIC for any taxable year during which a U.S. Holder holds our ordinary shares or ADSs, unless the holder makes
a mark-to-market election (as described below), the holder will, except as discussed below, be subject to special tax rules that have
a penalizing effect, regardless of whether we remain a PFIC, on (i) any excess distribution that we make to the holder (which generally
means any distribution paid during a taxable year to a holder that is greater than 125% of the average annual distributions paid in the
three preceding taxable years or, if shorter, the holder’s holding period for the ordinary shares or ADSs), and (ii) any gain realized
on the sale or other disposition, including, under certain circumstances, a pledge, of our ordinary shares or ADSs. Under the PFIC rules:
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The
excess distribution and/or gain will be allocated ratably over the U.S. Holder’s holding period for the ordinary shares or
ADSs; |
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The
amount of the excess distribution or gain allocated to the taxable year of the distribution or disposition and any taxable years
in the U.S. Holder’s holding period prior to the first taxable year in which we are classified as a PFIC, or a pre-PFIC year,
will be taxable as ordinary income; and |
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The
amount of the excess distribution or gain allocated to each taxable year other than the taxable year of the distribution or disposition
or a pre-PFIC year, will be subject to tax at the highest tax rate in effect applicable to the individuals or corporations, and the
interest charge generally applicable to underpayments of tax will be imposed on the resulting tax attributable to each such year. |
If
we are a PFIC for any taxable year during which a U.S. Holder holds our ordinary shares or ADSs and any of its non-U.S. subsidiaries
is also a PFIC, such holder would be treated as owning a proportionate amount (by value) of the shares of the lower-tier PFIC for purposes
of the application of these rules. Each U.S. Holder is advised to consult its tax advisors regarding the application of the PFIC rules
to any of our subsidiaries.
As
an alternative to the foregoing rules, a U.S. Holder of “marketable stock” in a PFIC may make a mark-to-market election with
respect to such ordinary shares or ADSs, provided that they are “regularly traded” (as specially defined under the Code)
on The Nasdaq Stock Market. No assurances may be given regarding whether the ordinary shares or ADSs will qualify, or will continue to
be qualified, as being regularly traded in this regard. If a mark-to-market election is made, the U.S. Holder will generally (i) include
as ordinary income for each taxable year that we are a PFIC the excess, if any, of the fair market value of ordinary shares or ADSs held
at the end of the taxable year over the adjusted tax basis of such securities and (ii) deduct as an ordinary loss the excess, if any,
of the adjusted tax basis of such securities over the fair market value of such securities held at the end of the taxable year, but only
to the extent of the net amount previously included in income as a result of the mark-to-market election. The U.S. Holder’s adjusted
tax basis in the ordinary shares or ADSs would be adjusted to reflect any income or loss resulting from the mark-to-market election.
If a U.S. Holder makes an effective mark-to-market election, in each year that we are a PFIC any gain recognized upon the sale or other
disposition of the ordinary shares or ADSs will be treated as ordinary income and loss will be treated as ordinary loss, but only to
the extent of the net amount previously included in income as a result of the mark-to-market election. U.S. Holders of our ordinary shares
or ADSs should consult their tax advisors regarding the availability of a mark-to-market election with respect to such ordinary shares
or ADSs.
If
a U.S. Holder makes a mark-to-market election in respect of a corporation classified as a PFIC and such corporation ceases to be classified
as a PFIC, the holder will not be required to take into account the mark-to-market gain or loss described above during any period that
such corporation is not classified as a PFIC.
Because
a mark-to-market election cannot be made for any lower-tier PFICs that a PFIC may own, a U.S. Holder who makes a mark-to-market election
with respect to the ordinary shares or ADSs may continue to be subject to the general PFIC rules with respect to such holder’s
indirect interest in any of our non-U.S. subsidiaries that is classified as a PFIC.
We
do not intend to provide information necessary for U.S. Holder’s to make qualified electing fund elections, which, if available,
would result in tax treatment different from the general tax treatment for PFICs described above. However, as described above under “Passive
Foreign Investment Company Considerations-PFIC Classification of TCB,” it is not presently expected that we will be classified
as a PFIC for the 2022 taxable year or the foreseeable future.
As
discussed above under “Dividends Paid on Ordinary Shares or ADSs”, dividends that we pay on the ordinary shares or ADSs will
not be eligible for the reduced tax rate that applies to qualified dividend income if we are classified as a PFIC for the taxable year
in which the dividend is paid or the preceding taxable year. In addition, if a U.S. Holder owns the ordinary shares or ADSs during any
taxable year that we are a PFIC, the holder must file an annual information return with the IRS. Each holder is urged to consult its
tax advisor concerning the U.S. federal income tax consequences of purchasing, holding, and disposing ordinary shares or ADSs if we are
or become a PFIC, including the possibility of making a mark-to-market election and the unavailability of the qualified electing fund
election.
Information
reporting and backup withholding
Certain
U.S. Holders are required to report information to the IRS relating to an interest in “specified foreign financial assets,”
including shares issued by a non-U.S. corporation, for any year in which the aggregate value of all specified foreign financial assets
exceeds $50 thousand (or a higher U.S. dollar amount prescribed by the IRS), subject to certain exceptions (including an exception for
shares held in custodial accounts maintained with a United States financial institution). These rules also impose penalties if a holder
is required to submit such information to the IRS and fails to do so.
In
addition, U.S. Holders may be subject to information reporting to the IRS and backup withholding with respect to dividends on and proceeds
from the sale or other disposition of our ordinary shares or ADSs. Information reporting will apply to payments of dividends on, and
to proceeds from the sale or other disposition of, our ordinary shares or ADSs by a paying agent within the United States to a holder,
other than holders that are exempt from information reporting and properly certify their exemption. A paying agent within the United
States will be required to withhold at the applicable statutory rate, currently 24%, in respect of any payments of dividends on, and
the proceeds from the disposition of, our ordinary shares or ADSs within the U.S. to a U.S. Holder (other than holders that are exempt
from backup withholding and properly certify their exemption) if the holder fails to furnish its correct taxpayer identification number
or otherwise fails to comply with applicable backup withholding requirements. U.S. Holders who are required to establish their exempt
status generally must provide a properly completed IRS Form W-9.
Backup
withholding is not an additional tax. Amounts withheld as backup withholding may be credited against a holder’s U.S. federal income
tax liability. A U.S. Holder generally may obtain a refund of any amounts withheld under the backup withholding rules by filing the appropriate
claim for refund with the IRS in a timely manner and furnishing any required information. Each U.S. Holder is advised to consult with
its tax advisor regarding the application of the United States information reporting rules to their particular circumstances.
Material
United Kingdom Tax Considerations
The
following is a description of the material U.K. tax considerations relating primarily to the ownership and disposal of our ordinary shares
or ADSs by the U.S. Holders described above. The U.K. tax comments set out below are based on current U.K. tax law as applied in Scotland,
and HMRC practice (which may not be binding on HMRC) as at the date of this summary, both of which are subject to change, possibly with
retrospective effect. They are intended as a general guide and, save where otherwise stated, only apply to you if you are not resident
in the U.K. for U.K. tax purposes and do not hold our ordinary shares or ADSs for the purposes of a trade, profession or vocation that
you carry on in the U.K. through a branch, agency or permanent establishment in the U.K. and if you hold our ordinary shares as an investment
for U.K. tax purposes and are not subject to special rules.
This
summary does not address all possible tax consequences relating to an investment in our ordinary shares or ADSs. In particular it does
not cover the U.K. inheritance tax consequences of holding our ordinary shares or ADSs. It assumes that the depositary or DTC has not
made an election under section 97A(1) of the Finance Act 1986. It assumes that we do not (and will not at any time) derive 75% or more
of our qualifying asset value, directly or indirectly, from U.K. land, and that we are and remain solely resident in the U.K. for tax
purposes. It assumes that the holder is not our officer or our employee (or of any related company of ours) and has not (and is not deemed
to have) acquired the ordinary shares or ADSs by virtue of an office or employment. It assumes that a holder of ordinary shares or ADSs
is the beneficial owner of the underlying ordinary shares for U.K. tax purposes. This summary is for general information only and is
not intended to be, nor should it be considered to be, legal or tax advice to any particular holder. Holders of our ordinary shares or
ADSs are strongly urged to consult their tax advisers in connection with the U.K. tax consequences of their investment in our securities.
U.K.
Taxation of Dividends and Distributions
We
will not be required to withhold amounts for or on account of U.K. tax at source when paying a dividend or distribution in respect of
our ordinary shares.
Individual
holders who hold our ordinary shares as an investment, who are not resident in the U.K. for U.K. tax purposes should not be subject to
U.K. income tax in respect of any dividends on our ordinary shares, unless they hold their ordinary shares in connection with any trade,
profession or vocation carried on (whether solely or in partnership) by them in the U.K. through a branch, agency or permanent establishment
in the U.K.. In these circumstances, such holder may, depending on his or her individual circumstances, be chargeable to U.K. income
tax in respect of our dividends.
Corporate
holders which are not resident in the U.K. for U.K. tax purposes should not be subject to U.K. corporation tax in respect of any dividends
on our ordinary shares, unless they carry on a trade in the U.K. through a permanent establishment to which the ordinary shares are attributable.
In these circumstances, such holders may, depending on their individual circumstances and if an exemption from U.K. corporation tax in
respect of dividend payments does not apply, be chargeable to U.K. corporation tax in respect of our dividends.
U.K.
Taxation of Capital Gains
An
individual holder who is not resident in the U.K. for U.K. tax purposes should not be liable to U.K. capital gains tax on capital gains
realized on the disposal of their ordinary shares unless such holder carries on (whether solely or in partnership) a trade, profession
or vocation in the U.K. through a branch or agency in the U.K. to which our ordinary shares are attributable. In these circumstances,
such holder may, depending on his or her individual circumstances, be chargeable to U.K. capital gains tax on chargeable gains arising
from a disposal of his or her ordinary shares.
Any
such individual holder of our ordinary shares who is temporarily non-resident for U.K. tax purposes will, in certain circumstances, become
liable to U.K. tax on capital gains in respect of gains realized while they were not resident in the U.K.
A
corporate holder of our ordinary shares which is not resident in the U.K. for U.K. tax purposes should not be liable for U.K. corporation
tax on chargeable gains realized on the disposal of our ordinary shares unless it carries on a trade in the U.K. through a permanent
establishment in the U.K. to which our ordinary shares are attributable. In these circumstances, a disposal of ordinary shares by such
holder may give rise to a chargeable gain or an allowable loss for the purposes of U.K. corporation tax.
Stamp
Duty and Stamp Duty Reserve Tax
The
discussion below relates to the holders of our ordinary shares or ADSs wherever resident, however it should be noted that special rules
may apply to certain persons such as market makers, brokers, dealers or intermediaries.
As
a general rule (and except in relation to depositary receipt systems and clearance services (as to which see below)), no UK stamp duty
or stamp duty reserve tax, or SDRT, is payable on the issue of the ordinary shares underlying the ADSs.
An
unconditional agreement to transfer ordinary shares will normally give rise to a charge to SDRT at the rate of 0.5% of the amount or
value of the consideration payable for the transfer. The purchaser of the shares is liable for the SDRT. Transfers of ordinary shares
in certificated form are generally also subject to stamp duty at the rate of 0.5% of the amount or value of the consideration given for
the transfer (rounded up to the next £5.00). Stamp duty is normally paid by the purchaser. The charge to SDRT will be cancelled
or, if already paid, repaid (generally with interest), where a transfer instrument has been duly stamped within six years of the charge
arising, (either by paying the stamp duty or by claiming an appropriate relief) or if the instrument is otherwise exempt from stamp duty.
Under
current UK legislation, an issue or transfer of ordinary shares or an unconditional agreement to transfer ordinary shares to a clearance
service or a depositary receipt system (including to a nominee or agent for, a person whose business is or includes the issue of depositary
receipts or the provision of clearance services) will generally be subject to SDRT (and, in the case of transfers, where the transfer
is effected by a written instrument, stamp duty) at a higher rate of 1.5% of the amount or value of the consideration given for the transfer
or, in certain circumstances, the value of the ordinary shares unless the clearance service has made and maintained an election under
section 97A of the UK Finance Act 1986, or a section 97A election. It is understood that HMRC regards the facilities of DTC as a clearance
service for these purposes and we are not aware of any section 97A election having been made by the DTC.
However,
based on current published HMRC practice following European Union case law in respect of the European Council Directives 69/335/EEC and
2009/7/EC, no SDRT is generally payable in respect of such an issue of ordinary shares and no SDRT or stamp duty is generally payable
in respect of such a transfer of ordinary shares where such transfer is an integral part of an issue of share capital. It is noted that
on January 31, 2020 the United Kingdom ceased to be a Member State of the European Union. Accordingly, the extent to which HMRC’s
position will remain as set out in this paragraph following the end of the transition period on December 31, 2020 is uncertain.
Any
stamp duty or SDRT payable on an issue or transfer of ordinary shares to a depositary receipt system or clearance service (although strictly
accountable by the clearance service or depositary receipt system operator or their nominee) will in practice generally be paid by the
transferors or participants in the clearance service or depositary receipt system. Specific professional advice should be sought before
incurring or reimbursing the costs of a 1.5% stamp duty or SDRT charge in any circumstances.
No
UK SDRT or stamp duty is required to be paid in respect of the issue or transfer of, or an agreement to transfer, ADSs (including by
way of a paperless transfer of ADSs through the facilities of DTC).
DESCRIPTION
OF SECURITIES WE ARE OFFERING
We
are offering 23,950 ADSs, pre-funded warrants to purchase 1,976,050 ADSs, and Series G Warrants to purchase up to
2,000,000 ADSs. For each pre-funded warrant we sell, the number of ADSs we are offering will be decreased on a one-for-one basis.
We are also registering the ADSs issuable from time to time upon exercise of the Warrants and pre-funded warrants offered hereby.
American
Depositary Shares (‘ADSs’)
The
description of our ADSs in Exhibit 4.7 of our 2023 Form 10-K is incorporated herein by reference.
On August 5,
2024, we effected a change to the ratio of our ADSs to our ordinary shares from one ADS representing twenty (20) ordinary shares
to one ADS representing two hundred (200) ordinary shares, or the ADS Ratio Change. Except as otherwise indicated, all information in
this prospectus, including the number of ADSs being offered and the assumed offering price gives retroactive effect to the ADS Ratio
Change.
Series
G Warrants
The
material terms and provisions of the Series G Warrants are summarized below. This summary of some provisions of the Series G Warrants
is not complete and is qualified in its entirety by the form of Series G Warrant, to be filed as an exhibit to the registration statement
of which this prospectus is a part. Prospective investors should carefully review the terms and provisions of the form of Series G Warrants for a complete description of the terms and conditions of the Series G Warrant.
Duration
and Exercise Price
Each
Series G Warrant will have an exercise price equal to £0.78 ($1.00 translated to U.S. dollars at the rate of £1.00
to $1.277 as of August 12, 2024) per ADS. The Series G Warrants will be immediately exercisable from the date of issuance
and may be exercised until the first anniversary of the initial issuance date. The exercise price and number of ADSs issuable upon exercise
is subject to appropriate adjustment in the event of stock dividends, stock splits, subsequent rights offerings, pro rate distributions,
reorganizations, or similar events affecting the Company’s ordinary shares and ADSs and the exercise price.
Exercisability
The
Series G Warrants will be exercisable, at the option of each holder, in whole or in part, by delivering to the Company a duly
executed exercise notice accompanied by payment in full for the number of ADSs purchased upon such exercise (except in the case of a
cashless exercise as discussed below). A holder (together with its affiliates) may not exercise any portion of such holder’s Series
G Warrants to the extent that the holder would own more than 4.99% (or, at the election of the holder, 9.99%) of the outstanding
ADSs immediately after exercise, except that upon prior notice from the holder to the Company, the holder may increase or decrease the
amount of ownership of outstanding ADSs after exercising the holder’s Series G Warrants up to 9.99% of the number of the
Company’s ordinary shares outstanding immediately after giving effect to the exercise, as such percentage ownership is determined
in accordance with the terms of the Series G Warrants, provided that any increase will not be effective until 61 days following
notice to us.
Cashless
Exercise
If,
at the time a holder exercises its Series G Warrants, a registration statement registering the resale of the Series G
Warrant ADSs by the holder under the Securities Act of 1933, as amended (the “Securities Act”) is not then effective or available,
then in lieu of making the cash payment otherwise contemplated to be made to the Company upon such exercise in payment of the aggregate
exercise price, the holder may elect instead to receive upon such exercise (either in whole or in part) the net number of ordinary shares
represented by ADSs determined according to a formula set forth in the Series G Warrants.
Trading
Market
There
is no established trading market for the Series G Warrants, and the Company does not expect an active trading market to develop.
The Company does not intend to apply to list the Series G Warrants on any securities exchange or other trading market. Without
a trading market, the liquidity of the Series G Warrants will be extremely limited.
Rights
as a Stockholder
Except
as otherwise provided in the Series G Warrants or by virtue of the holder’s ownership of the Company’s ADSs, such
holder of Series G Warrants does not have the rights or privileges of a holder of the Company’s ADSs, including any voting
rights, until such holder exercises such holder’s Series G Warrants. The Series G Warrants will provide that
the holders of the Series G Warrants have the right to participate in distributions or dividends paid on the Company’s
ADSs.
Fundamental
Transactions
If
at any time the Series G Warrants are outstanding, the Company, either directly or indirectly, in one or more related transactions
effects a Fundamental Transaction (as defined in the Series G Warrant), a Holder of Series G Warrants will be entitled
to receive, upon exercise of the Series G Warrants, the kind and amount of securities, cash or other property that such holder
would have received had they exercised the Series G Warrants immediately prior to the Fundamental Transaction.
Waivers
and Amendments
The
Series G Warrants may be modified or amended or the provisions of the Series G Warrants waived with the Company’s
and the holder’s written consent.
Pre-Funded
Warrants
General
The
term “pre-funded” refers to the fact that the purchase price of the pre-funded warrants in this offering includes almost
the entire exercise price that will be paid under the pre-funded warrants, except for a nominal remaining exercise price of $0.001. The
purpose of the pre-funded warrants is to enable investors that may have restrictions on their ability to beneficially own more than 4.99%
(or, at the election of such purchaser, 9.99%) of our outstanding ADSs following the consummation of this offering the opportunity to
invest capital into the Company without triggering their ownership restrictions, by receiving pre-funded warrants in lieu of ADSs which
would result in such ownership of more than 4.99% or 9.99%, as applicable, and receiving the ability to exercise their option to purchase
the ADSs underlying the pre-funded warrants at a nominal price at a later date.
The
following is a brief summary of certain terms and conditions of the pre-funded warrants being offered by us. The following description
is subject in all respects to the provisions contained in the form of pre-funded warrant, the form of which will be filed as an exhibit
to the registration statement of which this prospectus forms a part.
Exercise
Price
Pre-funded
warrants will have an exercise price of $0.001 per ADSs. The exercise price is subject to appropriate adjustment in the event of certain
stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting our ADSs and also
upon any distributions of assets, including cash, stock or other property to our stockholders.
Exercisability
The
pre-funded warrants are exercisable at any time after their original issuance and until exercised in full. The pre-funded warrants will
be exercisable, at the option of each holder, in whole or in part by delivering to us a duly executed exercise notice and by payment
in full of the exercise price in immediately available funds for the number of ADSs purchased upon such exercise. As an alternative to
payment in immediately available funds, the holder may elect to exercise the pre-funded warrant through a cashless exercise, in which
the holder would receive upon such exercise the net number of ADSs determined according to the formula set forth in the pre-funded warrant.
No fractional ADSs will be issued in connection with the exercise of a pre-funded warrant.
Exercise
Limitations
The
pre-funded warrants may not be exercised by the holder to the extent that the holder, together with its affiliates, would beneficially
own, after such exercise more than 4.99% of the ADSs then outstanding (including for such purpose the ADSs issuable upon such exercise).
However, any holder may increase or decrease such beneficial ownership limitation upon notice to us, provided that such limitation cannot
exceed 9.99%, and provided that any increase in the beneficial ownership limitation shall not be effective until 61 days after such notice
is delivered. Purchasers of pre-funded warrants in this offering may also elect prior to the issuance of the pre-funded warrants to have
the initial exercise limitation set at 9.99% of our outstanding ADSs.
Transferability
Subject
to applicable laws, the pre-funded warrants may be offered for sale, sold, transferred or assigned without our consent.
Trading
Market
There
is no established trading market for the pre-funded warrants and we do not expect a market to develop. In addition, we do not intend
to apply for the listing of the pre-funded warrants on any national securities exchange or other trading market. Without an active trading
market, the liquidity of the pre-funded warrants will be limited.
Fundamental
Transactions
In
the event of a fundamental transaction, as described in the pre-funded warrants and generally including any reorganization, recapitalization
or reclassification of our ADSs, the sale, transfer or other disposition of all or substantially all of our properties or assets, our
consolidation or merger with or into another person, the acquisition of more than 50% of our outstanding ADSs, or any person or group
becoming the beneficial owner of more than 50% of the voting power represented by our outstanding ADSs, upon consummation of such a fundamental
transaction, the holders of the pre-funded warrants will be entitled to receive upon exercise of the pre-funded warrants the kind and
amount of securities, cash or other property that the holders would have received had they exercised the pre-funded warrants immediately
prior to such fundamental transaction without regard to any limitations on exercise contained in the pre-funded warrants.
Rights
as a Shareholder
Except
as otherwise provided in the pre-funded warrant or by virtue of such holder’s ownership of shares of our ADSs, the holder of a
pre-funded warrant does not have the rights or privileges of a holder of our ADSs, including any voting rights, until the holder exercises
the pre-funded warrant. The pre-funded warrants will provide that holders have the right to participate in distributions or dividends
paid on our ADSs.
PLAN
OF DISTRIBUTION
The
terms of this offering were subject to market conditions and negotiations between us and prospective investors.
This is a best efforts offering and there is no minimum offering amount required as a condition to the closing of this offering. Because
there is no minimum offering amount required as a condition to closing this offering, we may sell fewer than all of the securities offered
hereby, which may significantly reduce the amount of proceeds received by us.
Investors
purchasing securities offered hereby will have the option to execute a securities purchase agreement with us. In addition to rights and
remedies available to all purchasers in this offering under federal securities and state law, the purchasers which enter into a securities
purchase agreement will also be able to bring claims of breach of contract against us.
The
nature of the representations, warranties and covenants in the securities purchase agreements shall include:
| |
● |
standard
issuer representations and warranties on matters such as organization, qualification, authorization, no conflict, no governmental
filings required, current in SEC filings, no litigation, labor or other compliance issues, environmental, intellectual property and
title matters and compliance with various laws such as the Foreign Corrupt Practices Act; and |
| |
|
|
| |
● |
covenants
regarding matters such as registration of warrant shares, no integration with other offerings, filing of a 6-K to disclose entering into
these securities purchase agreements, no shareholder rights plans, no material nonpublic information, use of proceeds, indemnification
of purchasers, reservation and listing of ADSs. |
We
expect to deliver the securities being offered pursuant to this prospectus on or about [●], 2024, subject to satisfaction of certain
customary closing conditions.
Fees
and Expenses
The
following table shows the amount per ADS and accompanying Warrants and amount per pre-funded warrant and accompanying
Warrants we will pay in connection with the sale of the securities in this offering.
| | |
Per ADS and Warrants | | |
Per Pre-Funded Warrant
and Warrants | | |
Total | |
| Public offering price | |
$ | 1.000 | | |
$ | 0.999 | | |
$ | 2,000,000 | |
| Proceeds to us (before expenses) | |
$ | 1.000 | | |
$ | 0.999 | | |
$ | 2,000,000 | |
Determination
of Offering Price
The
actual offering price of the securities we are offering has been negotiated between us and the investors in the offering based on the
trading of our ADSs prior to the offering, among other things. Other factors considered in determining the public offering price of the
securities we are offering include our history and prospects, the stage of development of our business, our business plans for the future
and the extent to which they have been implemented, an assessment of our management, the general conditions of the securities markets
at the time of the offering and such other factors as were deemed relevant.
Electronic
Offer, Sale and Distribution of Securities
The
Company may distribute prospectuses electronically.
Listing
Our
ADSs are listed on The Nasdaq Capital Market under the symbol “TCBP.”
Depositary
The
depositary for our ADSs is The Bank of New York Mellon.
EXPENSES
OF THE OFFERING
Set
forth below is an itemization of the total anticipated expenses expected to be incurred in connection
with the offer and sale of the ADSs by us. With the exception of the SEC registration fee and the FINRA filing fee, all amounts are estimates,
in United States dollars:
| SEC
registration fee |
|
$ |
1,500 |
|
| Legal
fees and expenses |
|
$ |
75,000 |
|
| Accounting
fees and expenses |
|
$ |
100,000 |
|
| Miscellaneous |
|
$ |
29,000 |
|
| Total |
|
$ |
205,500 |
|
LEGAL
MATTERS
We
are being represented by Sheppard, Mullin, Richter & Hampton LLP, New York, New York with respect to certain legal matters of United
States federal securities and New York state law. We are being represented by Addleshaw Goddard LLP, Glasgow, Scotland with respect to
certain legal matters of the law of Scotland and other applicable law of the United Kingdom and as to certain patent law matters by Murgitroyd
& Company Limited.
EXPERTS
The
consolidated financial statements of TC BioPharm (Holdings) plc incorporated by reference in TC BioPharm (Holdings) plc’s Annual
Report (Form 10-K) for the years ended December 31, 2023 and December 31, 2022, have been audited by Marcum LLP, independent registered
public accounting firm, as set forth in their report thereon, (which contains an explanatory paragraph describing conditions that raise
substantial doubt about the Company’s ability to continue as a going concern as described in Note 1 to the consolidated financial
statements) included therein, and incorporated herein by reference. Such consolidated financial statements are incorporated herein by
reference in reliance upon such report given on the authority of such firm as experts in accounting and auditing.
The
registered business address of Marcum LLP is 730 3rd Avenue, 11th Floor, New York, NY 10017, United States of America.
WHERE
YOU CAN FIND MORE INFORMATION
We
have filed with the SEC a registration statement on Form F-1 under the Securities Act relating to this offering. This prospectus does
not contain all of the information contained in the registration statement. The rules and regulations of the SEC allow us to omit certain
information from this prospectus that is included in the registration statement. Statements made in this prospectus concerning the contents
of any contract, agreement or other document are summaries of all material information about the documents summarized, but are not complete
descriptions of all terms of these documents. If we filed any of these documents as an exhibit to the registration statement, you may
read the document itself for a complete description of its terms.
You
may read and copy the registration statement, including the related exhibits and schedules, and any document we file with the SEC without
charge at the SEC’s public reference room at 100 F Street, N.E., Room 1580, Washington, DC 20549. You may also obtain copies of
the documents at prescribed rates by writing to the Public Reference Section of the SEC at 100 F Street, N.E., Room 1580, Washington,
DC 20549. Please call the SEC at 1-800-SEC-0330 for further information on the public reference room. The SEC also maintains an Internet
website that contains reports and other information regarding issuers that file electronically with the SEC. Our filings with the SEC
are also available to the public through the SEC’s website at http://www.sec.gov.
We
are subject to the information reporting requirements of the Exchange Act that are applicable to foreign private issuers, and under those
requirements are filing reports with the SEC. Those other reports or other information may be inspected without charge at the locations
described above. As a foreign private issuer, we are exempt from the rules under the Exchange Act related to the furnishing and content
of proxy statements, and our officers, directors and principal shareholders are exempt from the reporting and short-swing profit recovery
provisions contained in Section 16 of the Exchange Act. In addition, we are not required under the Exchange Act to file annual, quarterly
and current reports and financial statements with the SEC as frequently or as promptly as U.S. registrants whose securities are registered
under the Exchange Act. However, we are required to file with the SEC, within 120 days after the end of each fiscal year, or such applicable
time as required by the SEC, an annual report on Form 20-F containing financial statements audited by an independent registered public
accounting firm, and will furnish to the SEC, on Form 6-K, unaudited interim financial information.
We
maintain a corporate website at https://tcbiopharm.com/. Information contained on, or that can be accessed through, our website does
not constitute a part of this prospectus. We have included our website address in this prospectus solely as an inactive textual reference.
We will post on our website any materials required to be so posted on such website under applicable corporate or securities laws and
regulations, including, posting any XBRL interactive financial data required to be filed with the SEC and any notices of general meetings
of our shareholders.
INFORMATION
INCORPORATED BY REFERENCE
The
SEC allows us to “incorporate by reference” information into this prospectus, which means that we can disclose important
information to you by referring you to another document filed separately with the SEC. The documents incorporated by reference into this
prospectus contain important information that you should read about us.
The
following documents are incorporated by reference into this prospectus and any applicable prospectus supplement:
| |
● |
our
Annual Report on Form 10-K/A for the fiscal year ended December 31, 2023, filed with the SEC on April 29, 2024; |
| |
|
|
| |
● |
our
Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on April 1, 2024; |
| |
|
|
| |
● |
our
Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2024, filed with the SEC on May 15, 2024; |
| |
|
|
| |
● |
our
Current Reports on Form 8-K (other than Current Reports furnished under Item 2.02 or Item 7.01 of Form 8-K and exhibits filed on
such form that are related to such items) or Reports of Foreign Private Issuer on Form 6-K filed with the SEC on January
4, 2024, February
14, 2024, March
6, 2024, March
12, 2024, March
18, 2024, March
19, 2024, April
4, 2024, May
6, 2024, May
8, 2024, May
20, 2024, May
29, 2024, June
28, 2024, July
1, 2024, July
1, 2024, July
29, 2024, August
6, 2024 and August 8, 2024. |
| |
|
|
| |
● |
our
definitive Proxy Statement on Schedule 14A for our 2024 Annual Meeting of Shareholders, filed with the SEC on June 7, 2024; |
| |
|
|
| |
● |
the
description of our Common Stock contained in our registration statement on Form 8-A (File No. 001-41231) filed with
the SEC on January 14, 2022, including any amendments or reports filed with the SEC for the purposes of updating such description. |
All
documents subsequently filed by us (other than Current Reports furnished under Item 2.02 or Item 7.01 of Form 8-K and exhibits filed
on such form that are related to such items unless such Form 8-K expressly provides to the contrary) with the SEC pursuant to Section
13(a), 13(c), 14 or 15(d) of the Exchange Act, including those made after the date of the initial filing of the registration statement
of which this prospectus forms a part and prior to effectiveness of such registration statement, until we file a post-effective amendment
that indicates the termination of the offering of the shares of Common Stock made by this prospectus are deemed to be incorporated by
reference into this prospectus. Such future filings will become a part of this prospectus from the respective dates that such documents
are filed with the SEC.
Any
statement contained herein or in a document incorporated or deemed to be incorporated by reference herein shall be deemed to be modified
or superseded for purposes hereof to the extent that such statement contained herein or in any other subsequently filed document, which
is also incorporated or deemed to be incorporated herein, modifies or supersedes such statement. Any such statement so modified or superseded
shall not be deemed, except as so modified or superseded, to constitute a part of this prospectus.
You
can obtain any of the filings incorporated by reference into this prospectus through us or from the SEC through the SEC’s website
at http://www.sec.gov. We will provide, without charge, to each person, including any beneficial owner, to whom a copy of this prospectus
is delivered, upon written or oral request of such person, a copy of any or all of the reports and documents referred to above which
have been or may be incorporated by reference into this prospectus. You should direct requests for those documents to:
TC
BioPharm (Holdings) plc
Maxim
1, 2 Parklands Way
Holytown,
Motherwell, ML1 4WR
Scotland,
United Kingdom
+44
(0) 141 433 7557
We
maintain an internet site at http://www.tcbiopharm.com. Our website and the information contained on or connected to it shall not be
deemed to be incorporated into this prospectus or the registration statement of which it forms a part.
23,950
AMERICAN DEPOSITARY SHARES REPRESENTING 4,790,000 ORDINARY SHARES
AND
1,976,050 PRE-FUNDED WARRANTS TO PURCHASE UP TO
1,976,050
AMERICAN DEPOSITARY SHARES
AND
2,000,000 SERIES G WARRANTS TO PURCHASE UP TO 2,000,000 AMERICAN DEPOSITARY SHARES
(and
1,976,050 American Depositary Shares representing 395,210,000 ordinary shares underlying the Pre-Funded Warrants and 2,000,000 American
Depositary Shares representing 400,000,000 ordinary shares underlying the Series G Warrants)
TC
BIOPHARM (HOLDINGS) PLC
PRELIMINARY
PROSPECTUS
August
12, 2024
Grafico Azioni TC BioPharm (NASDAQ:TCBP)
Storico
Da Nov 2024 a Dic 2024
Grafico Azioni TC BioPharm (NASDAQ:TCBP)
Storico
Da Dic 2023 a Dic 2024
