Dear Fellow Shareholder,
As we come to the end of 2022, I am pleased to provide an update
for our shareholders. In keeping with good corporate practice and
US Securities and Exchange Commission (SEC) regulations, we have
refrained from answering individual queries from shareholders until
we were able to provide information to all shareholders at the same
time.
Our priorities continue to be our clinical programs, repurposing
anti-Tumor Necrosis Factor (TNF) drugs for treating Dupuytren’s
disease, frozen shoulder and post-operative delirium.
The Dupuytren’s contracture trial phase 2B trial, led by Prof
Nanchahal, the results of which we have previously announced,
exceeded our expectations. It also showed that the treatment is
likely to be cost-effective. Now, after obtaining scientific advice
from the UK Medicines and Healthcare products Regulatory Agency
(“MHRA”), the UK equivalent of the US Food and Drug Administration
(“FDA”), and after discussions with our regulatory consultants in
the United States and United Kingdom, we made the decision to begin
preparing all the material necessary to seek marketing
authorization in the UK. Based on the guidance received from our
regulatory consultants on the time required to prepare the
marketing authorization application, we currently plan on filing
the application in mid-2023. In seeking a marketing authorization,
we plan to engage a specialized consultant, Dr. Keith Watson, who
spent nearly five years with the MHRA as a reviewer of biologics
product applications, later serving as Director of Global
Regulatory Affairs, Biologics Strategic Development Group at
AbbVie, and more recently Vice President of Regulatory Affairs for
Celltrion Inc. He now manages his own regulatory consulting
practice. After reviewing our program and data, Dr. Watson stated,
“This is re-purposing of an approved medicine for a new indication.
Since Dupuytren’s contracture may be considered a seriously
debilitating disease where there is an unmet medical need to be
fulfilled, it may be possible to seek a Conditional Marketing
Authorization (CMA) to include in our submission a real-world data
(RWD) study comparing adalimumab to current standard of care in
Dupuytren’s contracture with the objective of showing
superiority.”
Dupuytren’s disease begins as a small nodule in the palm of the
hand. Over time, the cells in this nodule generate fibrous cords,
that pull the fingers into the palm. The team led by Professor
Nanchahal discovered that injecting anti-TNF drugs into the nodule
may have the potential to stop this process. All current therapies,
of which surgery is the most common, can be used only when the
fingers are contracted and the patient already has the disability.
The participants recruited to the phase 2b clinical trial had
nodules of early-stage Dupuytren’s disease, which were injected
with anti-TNF or placebo. The trial met the primary endpoint of
nodule hardness and the secondary endpoint of nodule size at 12
months. It is noteworthy that both the hardness and size of the
nodules continued to decrease further for a period of 9 months
after the final injection. Because it is a slowly progressing
disease, participants would need to be followed for many years to
show a significant difference in the development of finger
contractures or progression to surgery, which is not practical
given the very slow progression of the disease.
A published study from the Netherlands showed that increase
in nodule size correlates with finger flexion deformity and we
reason that a reduction in nodule size would conversely mean that
fingers are less likely to contract. As previously disclosed, the
MHRA reviewed the primary and secondary endpoints in the phase 2b
trial and the data provided by the Company and noted that it has
not been shown that reducing nodule size via treatment would lead
to improvements in terms of Dupuytren’s disease progression. We
plan to continue to collect all available data to address the point
made by the MHRA. In addition, we may conduct a follow-on study to
address the requirements of the MHRA, the EU, and the US FDA. We
expect Dr. Watson will provide us advice regarding the best path
forward assuming we receive Conditional Marketing Authorization
(CMA). With the recent financing complete, the Company is
proceeding with the preparation of the necessary CMA application
documents. It is a very substantial, but worthwhile task.
When the Dupuytren’s trial was started, the only available high
concentration, citrate free preparation of adalimumab was Humira
from AbbVie. However, we are now aware of seven other companies
with similar preparations and we are in contact with several of
them with a view towards a potential future partnering
arrangement.
Enrollment to the trial of anti-TNF for early-stage frozen
shoulder is slower than anticipated in the UK as patients typically
present to physical therapists and the processes are subject to
delays. In the USA, all such patients are seen by orthopedic
physicians, who are relatively easy to access. The trial team has
implemented several strategies to improve recruitment and we hope
that these will be effective.
Preparation for the trial of anti-TNF to prevent the development
of postoperative delirium remains on track and we anticipate that
the first patient will be recruited in the first half of 2023.
Our focus remains on our clinical portfolio which is the three
new indications for TNF blockade discussed above and we plan to
continue to evaluate the timing and cost/benefit of additional
ongoing research for our early discovery programs.
Our HMGB1 program continues to advance slowly. The molecular
dynamics for the binding of this molecule are extremely complex and
potentially need more extensive research in order to identify a
lead candidate.
The synthetic cannabinoid program is also moving along, albeit
slower than expected, with an emphasis on more effective
formulations to ensure that the cannabinoids are much more orally
available, as they are currently very poorly absorbed. We are
continuing with our research in this field towards the development
of a treatment for chronic pain. Assuming that the oral formulation
research efforts are successful, we may initiate early trials in
patients suffering from chronic pain, perhaps in early 2024.
As most of you know, we remain in some ongoing litigation and at
this point we have no further update on such matters other than
what has been reported in extensive detail in our most recent
Quarterly Report on Form 10-Q.
With the recent 1-for-20 reverse stock split being completed in
December, the Company expects to be in compliance with Nasdaq’s
ongoing listing rules. With a reduced burn rate and the financing
we have just completed, the Company is in a stronger cash position
to move forward with the programs outlined above, with the caution
that drug development and the process of dealing with regulatory
agencies is a slow and methodical process that may move slower and
be more difficult than we and our shareholders would desire.
However, we remain confident that we will be able to move our
products ahead as we have described.
Sincerely,
James Woody MD, PhD
CEO, 180 Life Sciences
About 180 Life Sciences Corp.
180 Life Sciences Corp. is a clinical-stage biotechnology
company focused on the development of novel drugs that fulfill
unmet needs in inflammatory diseases, fibrosis and pain by
leveraging the combined expertise of luminaries in therapeutics
from Oxford University, the Hebrew University and Stanford
University. 180 Life Sciences is leading the research into solving
one of the world’s biggest drivers of disease – inflammation. The
Company is driving groundbreaking studies into clinical programs,
which are seeking to develop novel drugs addressing separate areas
of inflammation for which there are no effective therapies. The
Company’s primary platform is a novel program to treat fibrosis
using anti-TNF (tumor necrosis factor).
Forward-Looking Statements
This press release includes “forward-looking statements”,
including information about management’s view of the Company’s
future expectations, plans and prospects, within the safe harbor
provisions provided under federal securities laws, including under
The Private Securities Litigation Reform Act of 1995 (the “Act”).
Words such as “expect,” “estimate,” “project,” “budget,”
“forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,”
“should,” “believes,” “predicts,” “potential,” “continue” and
similar expressions are intended to identify such forward-looking
statements. These forward-looking statements involve significant
risks and uncertainties that could cause the actual results to
differ materially from the expected results and, consequently, you
should not rely on these forward-looking statements as predictions
of future events. These forward-looking statements and factors that
may cause such differences include, without limitation, statements
regarding the timing of our planned marketing authorization
application (MAA) submission to the UK Medicines and Healthcare
products Regulatory Agency (MHRA), our ability to obtain approval
and acceptance thereof, the willingness of MHRA to review such MAA,
and our ability to address outstanding comments and questions from
the MHRA; statements about the ability of our clinical trials to
demonstrate safety and efficacy of our product candidates, and
other positive results; the uncertainties associated with the
clinical development and regulatory approval of 180 Life Sciences’
drug candidates, including potential delays in the enrollment and
completion of clinical trials, issues raised by the U.S. Food and
Drug Administration (FDA) and MHRA; the ability of the Company to
persuade MHRA that chosen endpoints do not require further
validation; timing to complete required studies and trials, and
timing to obtain governmental approvals; the accuracy of
simulations and the ability to reproduce the outcome of such
simulations in real world trials; 180 Life Sciences’ reliance on
third parties to conduct its clinical trials, enroll patients, and
manufacture its preclinical and clinical drug supplies; the ability
to come to mutually agreeable terms with such third parties and
partners, and the terms of such agreements; estimates of patient
populations for 180 Life Sciences planned products; unexpected
adverse side effects or inadequate therapeutic efficacy of drug
candidates that could limit approval and/or commercialization, or
that could result in recalls or product liability claims; 180 Life
Sciences’ ability to fully comply with numerous federal, state and
local laws and regulatory requirements, as well as rules and
regulations outside the United States, that apply to its product
development activities; the timing of filing, the timing of
governmental review, and outcome of, planned Investigational New
Drug (IND) applications for drug candidates; current negative
operating cash flows and a need for additional funding to finance
our operating plans; the terms of any further financing, which may
be highly dilutive and may include onerous terms, increases in
interest rates which may make borrowing more expensive and
increased inflation which may negatively affect costs, expenses and
returns; statements relating to expectations regarding future
agreements relating to the supply of materials and license and
commercialization of products; the availability and cost of
materials required for trials; the risk that initial drug results
are not predictive of future results or will not be able to be
replicated in clinical trials or that such drugs selected for
clinical development will not be successful; challenges and
uncertainties inherent in product research and development,
including the uncertainty of clinical success and of obtaining
regulatory approvals; uncertainty of commercial success; the
inherent risks in early stage drug development including
demonstrating efficacy; development time/cost and the regulatory
approval process; the progress of our clinical trials; our ability
to find and enter into agreements with potential partners; our
ability to attract and retain key personnel; changing market and
economic conditions; our ability to produce acceptable batches of
future products in sufficient quantities; unexpected manufacturing
defects; manufacturing difficulties and delays; competition,
including technological advances, new products and patents attained
by competitors; challenges to patents; product efficacy or safety
concerns resulting in product recalls or regulatory action; changes
in behavior and spending patterns of purchasers of health care
products and services; changes to applicable laws and regulations,
including global health care reforms; expectations with respect to
future performance, growth and anticipated acquisitions; the
continued listing of the Company’s securities on The NASDAQ Stock
Market; expectations regarding the capitalization, resources and
ownership structure of the Company; expectations with respect to
future performance, growth and anticipated acquisitions; the
ability of the Company to execute its plans to develop and market
new drug products and the timing and costs of these development
programs; estimates of the size of the markets for its potential
drug products; the outcome of current litigation involving the
Company; potential future litigation involving the Company or the
validity or enforceability of the intellectual property of the
Company; global economic conditions; geopolitical events and
regulatory changes; the expectations, development plans and
anticipated timelines for the Company’s drug candidates, pipeline
and programs, including collaborations with third parties; access
to additional financing, and the potential lack of such financing;
and the Company’s ability to raise funding in the future and the
terms of such funding; and the effect of rising interest rates and
inflation, and economic downturns and recessions. These risk
factors and others are included from time to time in documents the
Company files with the Securities and Exchange Commission,
including, but not limited to, its Form 10-Ks, Form 10-Qs and Form
8-Ks, and including the Annual Report on Form 10-K for the year
ended December 31, 2021, and Quarterly Report on Form 10-Q for the
quarter ended September 30, 2022, and future SEC filings. These
reports and filings are available at www.sec.gov and are available
for download, free of charge, soon after such reports are filed
with or furnished to the SEC, on the “Investors”—“SEC Filings”—“All
SEC Filings” page of our website at www.180lifesciences.com. All
subsequent written and oral forward-looking statements concerning
the Company, the results of the Company’s clinical trial results
and studies or other matters and attributable to the Company or any
person acting on its behalf are expressly qualified in their
entirety by the cautionary statements above. Readers are cautioned
not to place undue reliance upon any forward-looking statements,
which speak only as of the date made, including the forward-looking
statements included in this press release, which are made only as
of the date hereof. The Company cannot guarantee future results,
levels of activity, performance or achievements. Accordingly, you
should not place undue reliance on these forward-looking
statements. The Company does not undertake or accept any obligation
or undertaking to release publicly any updates or revisions to any
forward-looking statement to reflect any change in its expectations
or any change in events, conditions or circumstances on which any
such statement is based, except as otherwise provided by law.
Investor Contact:
Jason Assad
Director of IR
180 Life Sciences Corp
(678) 570-6791
Jason@180lifesciences.com
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