180 Life Sciences Corp. (NASDAQ: ATNF or the "Company"),
a clinical-stage biotechnology company with its lead indication in
Phase 2b/3, focused on the development of novel drugs that fulfill
unmet needs in inflammatory diseases, fibrosis and pain, today
released the following letter to stockholders from its Chief
Executive Officer, Dr. James Woody.
Dear Fellow Stockholder,
On the heels of the November 9, 2020, closing of our merger with
KBLM Merger Corp IV, resulting in 180 Life Sciences now being a
stand-alone publicly traded company and its common stock being
listed on The NASDAQ Capital Market under the symbol “ATNF”, I
wanted to take this opportunity to personally communicate with you.
It goes without saying that I appreciate your support in helping us
get to where we are today and want to update you on our planned
path moving forward.
As someone who has always believed that management is one of a
company’s most important assets and often the key to its ultimate
success, I want to start off by telling you a little about myself
and why I have taken on this role at this point in my career. I
also want to tell you about the world class team of scientists,
physicians, and executives that we have put together that now
comprise our management team and board of directors. I also want to
talk to you about our drug pipeline, our plans moving forward,
including what lies ahead for our company and our anticipated
critical milestones.
I have dedicated my life to the medical profession. Having more
than 25 years of biomedical research and management experience. I
was the founding CEO and served as the Chairman at OncoMed
Pharmaceuticals, Inc. I served as President at Roche Bioscience in
Palo Alto, CA. where I was responsible for all bioscience research
and development, ranging from genetics and genomics to
clinical development of numerous new pharmaceuticals.
I started my career in biotech as the Chief Scientific Officer
and Senior Vice President of Research and Development at Centocor,
where I led the team responsible for developing Remicade, the first
of the TNF (tumor necrosis factor) inhibitor biologics. This was in
collaboration with Prof. Sir Marc Feldmann, one of the
founders of 180 Life Sciences and the current Co-Chairman of the
Board of Directors. Marc and I go back a long way, to the late 70s.
Remicade was a breakthrough product, it was the first anti-TNF to
show dramatic efficacy, and triggered the “antibody revolution”.
According to a report in FiercePharma. Remicade sales topped $7
billion USD in 2016 and were $5 billion in 2019.
Prior to that, I served as a Commanding Officer and Director at
U.S. Naval Medical Research and Development Command in Bethesda,
Maryland, where I was responsible for a wide range of medical
research and development activities ranging from transplantation
research to infectious diseases. In our transplantation research
program, which I headed, we founded the National Marrow Donor
program, an amazing success for individuals who need a bone marrow
transplant but do not have a matched donor.
I was responsible for the surveillance, detection and therapy
for all Biologic Warfare Agents and Infectious Diseases in the
first Gulf War and was honored to be awarded the U.S. Navy Legion
of Merit for my service. I learned a lot about effective management
in the Navy.
I continue to serve as a Director of several medical companies,
including ProteinSimple, Neuraltus Pharmaceuticals, Talima
Therapeutics, Inc., FortéBio Inc., and IntegenX Inc. I also
previously served as a Director of Bayhill Therapeutics, Inc,
TetraLogic Pharmaceuticals, Inc., and OncoMed Pharmaceuticals,
Inc.
While I believe my background and experience enables me to lead
180 Life Sciences, I also fundamentally believe in the importance
of having a high-quality team around me to help ensure we reach our
collective goal of creating sustainable stockholder value. I’d now
like to introduce the rest of our management team that consists of
highly regarded and accomplished executives, scientists and
physicians whose backgrounds really speak for themselves.
Prof. Sir Marc Feldmann, Co-Chairman of the Board
of Directors – A leading immunologist, professor at
the University of Oxford and the inventor of anti-TNF
therapy, which according to Research and Markets, in is the world's
biggest-selling drug class, with sales of approximately $40
billion in recent years. With his team, he discovered the
advantages of targeting TNF, as well as using combination
therapies. Working with Sir Ravinder Maini and myself, Centocor
Biotech (now Janssen Biotech, a part of Johnson & Johnson)
licensed Prof. Feldmann's key patent to develop Remicade, which is
one of the best-selling drugs in the world according to
FiercePharma, and AbbVie licensed his patents for use with Humira,
cited as the world's best-selling drug by BioProcess International.
Sir Marc is intimately involved in the development of 2 of the 3
projects being developed by 180 Life Sciences, new uses of anti-TNF
and synthetic cannabidiol analogues. He is a Fellow of the Royal
Society and a foreign Member of the National Academy of Sciences,
USA.
Prof. Lawrence Steinman, Co-Chairman of the Board
of Directors – Professor of Neurology and Pediatrics
at Stanford University. Prof. Steinman’s work led to the
development of Tysabri, a highly effective treatment for multiple
sclerosis and inflammatory bowel disease. Tysabri was sold to
Biogen for $3.25 billion in 2013. He also founded Neurocrine
Biosciences, a NASDAQ-listed company with an
approximately $8.6 billion market cap. His lab
at Stanford University is dedicated to understanding the
pathogenesis of autoimmune diseases, particularly multiple
sclerosis. He served on the Board of Centocor and currently serves
as an advisor to Atreca. Prof. Steinman received a B.A.
from Dartmouth College and M.D. from Harvard Medical
School, and is a Member of the National Academy of Sciences,
USA.
Dr. Jonathan Rothbard, Chief Scientific
Officer – Responsible for helping to establish a
variety of biotech startups, including Amylin Pharmaceuticals
(which was sold to AstraZeneca and Bristol-Myers Squibb for $7
billion), ImmuLogic, CellGate and Cardinal Therapeutics. Dr.
Rothbard completed his post-doctoral fellowship with
Dr. Gerald Edelman at Rockefeller
University and served as Head of the Molecular Immunology
laboratory at the Imperial Cancer Research Fund in London,
England, before returning to Stanford University.
Prof Steinman and Dr Jonathan Rothbard are developing the Alpha
7, agonists to α7 Nicotinic Acetylcholine receptor.
We also previously announced the appointments of Professor
Richard Barker, Larry Gold MD., Shoshana Shendelman PhD., and
Donald McGovern Jr., to our Board of Directors. They are very
experienced and highly regarded in the biotech Industry.
I’d like to now tell you a little about our exciting pipeline
which includes three clinical programs addressing the following
indications:
- Early
Dupuytren's contracture, a fibrotic disease of the hand, which is
in Phase 2b/3, with results expected in 2H 2021. Dupuytren’s
disease is estimated to impact over 11 million Americans, and about
the same number in the European Union. Our trial is focused on
treating early and preventing the progress of the disease to avoid
the hand contracture disability. This project is entirely grant
funded.
- Frozen
shoulder, with a grant to initiate the clinical study recently
awarded by the National Institute of Health Research, U.K. Due to
COVID-19, we plan to start the trial in Q3 2021. Again, we plan to
try and avoid the pain and disability associated with Frozen
Shoulder by treating early.
- Post-operative
cognitive delirium disorder and dysfunction, a major unmet clinical
need occurring in the elderly patient population, most commonly
following lengthy anesthesia during hip fracture repair or after
CABG (Coronary Artery Bypass Graft). We hope to be able to reduce
or prevent this dysfunction.
Additionally, our pre-clinical discovery programs include:
- A program focused on
the development of unique, Food and Drug Administration
(FDA)-approved, pharmaceutical-grade oral synthetic cannabidiol
analogs to treat pain that is specifically focused on arthritis.
This project is run in Israel and Oxford, England. We are working
with one of the foremost authorities on Cannabis chemistry and the
discoverer of the body’s own “cannabinoids”, Prof Raphael
Mechoulam. To optimize uptake we are working with an expert in
cannabinoid drug delivery, Prof Avi Domb in Jerusalem, Israel.
- The α7nAChR program,
which aims to develop α7nAChR agonists for the treatment of
inflammatory diseases, initially ulcerative colitis induced after
cessation of smoking.
We look forward to the results of our Phase 2b/3 study on
Dupuytren’s contracture, a disease that impacts a large total
addressable market estimated to comprise over 22 million in the US
and EU. We believe that if we are able to successfully
commercialize this drug, of which there can be no assurance, it has
the potential to generate significant revenues for the Company.
It is important to note that our business model itself is unique
for a biotech company. Almost all our clinical studies to date have
been funded in full through grants. While ultimately, we intend to
fund some studies internally, we anticipate our operating expenses
will remain low relative to our peers. There are many advantages of
doing clinical development mostly with academic leaders, both in
cost, efficiency and credibility.
I’d like to close by telling you why I took the role as CEO and
what my personal goal is for the Company. My goal and the goal of
the other members of management is to build stockholder value by
developing world leading products to solve unmet medical needs. As
management and insiders currently own over 50% of the Company, we
believe our goals are directly aligned with the stockholders of the
Company. Many members of our management team have not taken a
salary to date. Future compensation will be conservative, favoring
equity over cash.
The good news for stockholders is that my team and I have done
this before. We are a team who have developed not one but many
blockbuster drugs. Our goal for 180 Life Sciences is to execute on
a model we all know well, building upon past success, experience,
and relationships to bring our pipeline candidates to market. We
look forward to working hard for our collective benefit and
communicating with you regularly moving forward. Thank you again
for your invaluable support.
Sincerely,
James Woody MD, PhD
CEO, 180Life 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), with its lead program in
phase 2b/3 clinical trials.
Forward-Looking StatementsThis 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 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; 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, as well as in the definitive proxy statement/prospectus that
the Company filed in connection with the recent merger. 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
Corp678-570-6791Jason@180lifesciences.com
Media Relations:
David SchullDavid.Schull@russopartnersllc.com (212) 845-4271
Eric AndoEric.Ando@russopartnersllc.com (646) 218-4604
180 Life Sciences (NASDAQ:ATNFW)
過去 株価チャート
から 5 2024 まで 6 2024
180 Life Sciences (NASDAQ:ATNFW)
過去 株価チャート
から 6 2023 まで 6 2024