Press Releases

180 Life Sciences Corp. Enters into a License Agreement with University of Oxford for Regenerative Molecule HMGB1 for Liver Diseases

PALO ALTO, Calif., Dec. 15, 2021 (GLOBE NEWSWIRE) -- 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 announced that it has entered into a new, exclusive global licensing agreement with The University of Oxford (“Oxford”) for the development and commercialization of HMGB1, a regenerative molecule for promoting liver repair and regeneration. Under the terms of the transaction, the Company will pay Oxford a small one-time upfront license fee, which will have an insignificant impact on the 2022 expenditure rate; and any further payments are contingent upon the achievement of certain clinical, regulatory and sales milestones.

There is currently no approved therapeutic for limiting damage and fibrosis in patients with liver disorders such as Non-Alcoholic Steatohepatitis (“NASH”). 180 Life Sciences, through a collaboration led by Professor Jagdeep Nanchahal at the University of Oxford, is pursuing a program to identify novel therapeutic targets. The team has identified a physiological pathway, activated by the molecule HMGB1, that has been shown to lead to regeneration of tissues by targeting endogenous stem and progenitor cells. Together with the University of Oxford, the Company plans to proceed with scaling up and Good Manufacturing Practice (GMP) production, as well as safety and toxicity testing in preparation for a planned Investigational New Drug (IND) application filing.

According to a 2016 article by Rinella, M.E. and A.J. Sanyal, entitled, “Management of NAFLD: a stage-based approach”, published in the Naturel Reviews Gastroenterol Hepatol, non-alcoholic fatty liver disease (NAFLD) has emerged as the most common cause of chronic liver condition in the Western world, affecting 30% of the adult population in the USA and encompassing non-alcoholic fatty liver (NAFL) and non-alcoholic steatohepatitis (NASH). NAFL and NASH each carries significant morbidity and mortality risks; 2-3% NAFL and 15-20% NASH patients progress to cirrhosis, with some developing hepatocellular carcinoma.

Dr. James Woody, CEO of 180 Life Sciences, commented, “Liver diseases represent a large unmet medical need. NASH is expected to become the principal indication for liver transplantation in the USA, with the attendant problems of immunosuppression and shortages of suitable donors. We believe an effective treatment that promotes regeneration and limits hepatocellular damage and fibrosis has the potential to revolutionize the management of patients.”

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, the uncertainties associated with the clinical development and regulatory approval of 180 Life Science’s drug candidates, including potential delays in the enrollment and completion of clinical trials; the potential that earlier clinical trials and studies may not be predictive of future results; 180 Life Sciences’ reliance on third parties to conduct its clinical trials, enroll patients, and manufacture its preclinical and clinical drug supplies; 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; 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 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 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. 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 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.

Investors:

Jason Assad
Director of IR
180 Life Sciences Corp
(678) 570-6791
Jason@180lifesciences.com

Media Relations:

Russo Partners
David Schull
David.Schull@russopartnersllc.com     
(212) 845-4271 

Released December 15, 2021