180 Life Sciences Corp. (NASDAQ: ATNF, “180 Life Sciences” or
the "Company"), a clinical-stage biotechnology company focused on
the development of novel drugs that fulfill unmet needs in
inflammatory diseases, fibrosis and pain, today released the
following letter to shareholders from its Chief Executive Officer,
Dr. James Woody.
Dear Fellow Shareholders,
As you may recall, I previously authored a letter to you at the
end of August 2021. I continue to believe ongoing communications
with our shareholders is a foundational responsibility of being a
public company. This belief, along with recent market turmoil, has
encouraged me to write to you today.
To begin, I would like to comment on our current share price. On
a macro basis, and in general, we are not an anomaly as both the
market and the biotech sector have been declining precipitously.
The factors contributing to the general decline over the last month
appear to be systematic and hence, not unique to any particular
company. The Company’s fundamentals have not changed since our
release of positive clinical data in early December 2021, as
discussed below. According to a biopharmaceutical sector report
released on January 23, 2022, by Torreya, a global life sciences
investment banking boutique, a confluence of factors is at play,
contributing to a 28% decline in biotech value for the last month.
Torreya further notes that underlying sector fundamentals are
certainly not the source of the biotech carnage. They posit that
four factors could explain the market decline, some more impactful
than others while some only serving as the initial catalysts. The
four factors include: 1) hedge fund redemptions and forced
liquidations, 2) mean-reversion, with people who achieved capital
gains in the pandemic now taking out their gains, 3) fear of the
Fed tightening monetary policy and rising inflation and 4) rampant
short-selling. Although we cannot influence these factors, we
continue to push forward with our mission: to bring much-needed
therapies to patients. Moreover, as previously disclosed in our SEC
filings, certain executives and board members of the Company have
purchased shares in the open market at a price per share higher
than our current trading price and such executives remain excited
about the future potential of the Company. While we are not pleased
with the recent drop, we have an unfaltering belief in the Company
and remain focused on creating fundamental value that we expect
will ultimately be reflected over time.
Turning your attention to our clinical programs, I would like to
recap that in December 2021, we had announced top line results for
our Phase 2b trial in early Dupuytren’s Contracture, the Company’s
most advanced clinical program. The asset is a reformulated and
repurposed anti-tumor necrosis factor (TNF) (adalimumab) with a
comprehensive new method of use intellectual property (IP)
portfolio, which includes patents both owned by 180LS and
exclusively licensed from Oxford University. As previously
reported, the study met both primary and secondary endpoints with
statistical significance by diminishing the hardness and size of
the Dupuytren’s nodules, respectively. To our knowledge, this is
the first rigorous randomized, placebo-controlled, double-blinded
trial for preventing the progression of this condition. Further,
enrolled patients exhibited a high compliance rate, almost all of
whom returned for all injections and experienced no related serious
adverse events.
We look forward to the anticipated publication of these results
in a peer-reviewed journal, expected over the next months, which we
believe will lend credence to the work and represent significant
progress in the field of Dupuytren’s Contracture. Professor
Nanchahal submitted the manuscript to a preeminent clinical journal
shortly in advance of his December 2021 presentation at the
International Dupuytren Symposium.
We believe there is a tremendous market opportunity for treating
early-stage Dupuytren’s, as we are not aware of any competitors
developing such targeted therapies. Based on independent market
research (both primary and secondary) conducted by Red Sky Partners
on behalf of the Company, the US patient population for Dupuytren’s
stands at approximately 16 million, of which approximately 3
million have sufficiently bent fingers to need treatment. Red Sky
Partners also estimates that initial sales for the US alone range
from $300-350M and potential expansion to add another $500-800M. We
believe that there are several factors that could make this $800M
number substantially greater: 1) the Phase 2b study's high
compliance rate of over 85% despite the COVID outbreak suggests
that patients potentially favor prevention over disability (seeking
treatment before the fingers contract) and 2) the projected sales
only account for the US market, not the UK/EU and the rest of the
world.
In an effort to bring this therapy to market, we have engaged
regulatory consultants to assist in discussions with the US Food
and Drug Administration (FDA) and the UK equivalent, the Medicines
and Healthcare products Regulatory Agency (MHRA), to help determine
the optimal path forward to a potential regulatory approval.
Initial meetings with these regulatory bodies are currently planned
for late March or early April of 2022.
Our other clinical programs in frozen shoulder and
post-operative cognitive delirium (POCD) are expected to be
primarily funded through non-dilutive grants. We currently plan to
start the trial for frozen shoulder in Q1/Q2 2022 and for POCD in
Q3/Q4 2022.
On the business development front, we are exploring strategic
opportunities for our lead indication in Dupuytren’s. We are in
multiple conversations with potential partners to advance our Phase
2b data and we look forward to these potential collaborations.
On the operational front, while we worked through the
SPAC-related challenges in the last year, we ensured that we
maintained financial discipline while striving to achieve our
clinical goals. In light of the depressed share price and
unanticipated macro-economic headwinds, we have looked inward to
establish tighter budgets and ensure strict adherence in order to
extend our cash runway as far as feasible. We believe the extension
will afford us a longer window of opportunity to capitalize on
various potential sources of non-dilutive funding, including grants
or upfront payments from potential business development initiatives
highlighted above.
Moreover, we are looking for opportunities to deploy our capital
in the most value-additive endeavors outside of our development
programs. As a first step, we will be expanding our PR and IR
efforts, instituting a more integrated and mutually reinforcing
strategy going forward. We will pursue both “push” and “pull”
marketing efforts, exploring various avenues to optimize messaging,
dissemination and amplification, with a focus on those that will
best reach our targeted audience of patients, investors, advocacy
groups and key opinion leaders.
Now more than ever, we are looking forward and focused on
execution. Our goal for 180 Life Sciences is to execute on a model
we all know well, building upon past successes, experiences and
relationships to bring our pipeline candidates to market. Thank you
again for your invaluable support.
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 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 relating to expectations regarding
the capitalization, resources, and funding of the Company;
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 will not be able to be replicated in
clinical trials or that such drugs selected for clinical
development will not be successful; the successful implementation
of the Company’s research and development programs and
collaborations and the Company’s interpretation of the results and
findings of such programs and collaborations and whether such
results are sufficient to support the future success of the
Company’s product candidates; the success, timing and cost of the
Company’s ongoing clinical trials and anticipated clinical trials
for the Company’s current product candidates, including statements
regarding the timing of initiation, pace of enrollment and
completion of the trials (including our ability to fully fund our
disclosed clinical trials, which assumes no material changes to our
currently projected expenses), futility analyses, presentations at
conferences and data reported in an abstract, and receipt of
interim results (including, without limitation, any preclinical
results or data), which are not necessarily indicative of the final
results of the Company’s ongoing clinical trials; uncertainty of
commercial success; 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
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; potential 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. 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. These
reports and filings are available at www.sec.gov. All subsequent
written and oral forward-looking statements concerning the Company,
the transactions described herein 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.
The forward-looking statements included in this press release 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.
Investors:
Jason AssadDirector of IR180 Life Sciences Corp(678)
570-6791Jason@180lifesciences.com
Media Relations:
Russo PartnersDavid SchullDavid.Schull@russopartnersllc.com(212)
845-4271
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