PALO ALTO, Calif., Jan. 17, 2023 (GLOBE NEWSWIRE) — 180 Life Sciences Corp. (NASDAQ: ATNF) (“180 Life Sciences” or “Company”) announced today that the company has contracted with Kinexum, a strategic advisory firm. , to support the Company in submitting a Marketing Authorization (MAA) application for adalimumab for the treatment of advanced, early-stage Dupuytren’s disease. The MAA will be submitted to the UK Medicines and Healthcare products Regulatory Agency (MHRA or Agency). As part of the application, the company expects to request a Conditional Marketing Authorization (CMA), which assures the agency that long-term results data will be forthcoming. Including costs associated with the Kinexum agreement, the Company expects it will spend, in total, approximately $900,000 to $1,000,000 in the next three quarters for activities associated with MHRA filings and other regulatory preparations.
About 180 Life Sciences Corp.
180 Life Sciences Corp. is a clinical-stage biotechnology company leading pioneering studies in clinical programs that seek to address key unmet medical needs. The company is focused on a new program to treat several inflammatory disorders using TNF (Tumor Necrosis Factor).
About Kinexum (www.kinexum.com)
Since 2003, Kinexum has been a leader in helping clients through the regulatory, clinical and product development process, from first approach to regulatory agency to post-marketing negotiations, for a broad range of therapeutic areas and modalities.
This press release contains “forward-looking statements,” including information about management’s view of the Company’s future expectations, plans, and prospects, within the safe harbor provisions of federal securities laws, including under the Private Securities Litigation Reform Act of 1995 (“represents “). Words like “anticipate,” “estimate,” “project,” “budget,” “anticipate,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” Believes”, “expects”, “potential”, “continues” and similar expressions are intended to identify such forward-looking statements. Such forward-looking statements involve significant risks and uncertainties that could cause actual results to differ materially from expected results and, therefore, you should not rely on these Forward-looking statements as predictions of future events.These statements and forward-looking factors that may cause such discrepancies include, but are not limited to, statements regarding the timing of our planned submission of a Marketing Authorization (MAA) application to the UK Medicines and Healthcare products Regulatory Agency (MHRA), and our ability to on obtaining conditional or final approval thereof, MHRA’s willingness to accept or review such MAA, and our ability to address outstanding comments and questions from MHRA; statements about the ability of our clinical trials to demonstrate the safety and efficacy of our product candidates, and other positive outcomes; uncertainties associated with clinical development and regulatory approval for 180 drugs life sciences candidates, including potential delays in registration and completion of clinical trials, or issues raised by MHRA, the US Food and Drug Administration (FDA), or other regulatory authorities in countries or regions; The company’s ability to convince any of the regulatory authorities that it chose endpoints does not require further verification; The timing of completing the required studies and experiments, and the timing of obtaining government approvals; the accuracy of simulations and the ability to reproduce the results of these simulations in real-world experiments; 180 Life Sciences reliance on third parties to conduct its clinical trials, enroll patients, and manufacture preclinical and clinical drug supplies; the ability to reach mutually agreed terms with third parties and partners, and the terms of such agreements; patient population estimates for 180 planned life sciences products; unexpected adverse side effects or inadequate therapeutic efficacy of drug candidates that could limit approval and/or marketing, or that could result in product recalls or liability claims; 180 Life Sciences is able to fully comply with many 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 submission, the timing of government review, and the results of investigational new drug (IND) applications planned for drug candidates; current negative operating cash flows and the need for additional financing to fund our operating plans; The terms of any additional financing, which may be too lenient and may include onerous terms, increases in interest rates which may make borrowing more expensive and increased inflation which may adversely affect costs, expenses and returns; statements regarding expectations regarding future agreements relating to the supply of materials, licensing, and marketing of products; availability and cost of materials required for the experiments; the risk that initial drug results are not predictive of future outcomes or will not be able to be replicated in clinical trials or that such drugs selected for clinical development will not be successful; the challenges and uncertainties inherent in product research and development, including uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success; the risks inherent in the early stage of drug development including demonstration of efficacy; development time/cost and regulatory approval process; advance our clinical trials; our ability to find and enter into agreements with potential partners; our ability to attract and retain key employees; 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 obtained by competitors; patent challenges; concerns about product efficacy or safety resulting in a product recall or regulatory action; changes in the behavior and spending patterns of buyers of healthcare products and services; changes in applicable laws and regulations, including global healthcare reforms; expectations regarding future performance, growth, and expected acquisitions; The company’s securities continue to be listed on the Nasdaq Stock Exchange. expectations regarding the company’s capitalization, resources and ownership structure; expectations regarding future performance, growth, and expected acquisitions; the Company’s ability to implement its plans to develop and commercialize new drug products and the timing and costs of such development programs; market size estimates for its potential pharmaceutical products; the result of an existing lawsuit involving the company; potential future litigation involving the Company or the validity or enforceability of the Company’s intellectual property; global economic conditions; geopolitical events and regulatory changes; projections, development plans, and projected timelines for the Company’s candidate drugs, pipelines, and programs, including collaborations with third parties; obtaining additional financing, and the possibility of a lack of such financing; the Company’s ability to raise financing in the future and the terms of such financing; And the impact of high interest rates, inflation, recession and recession. 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, Form 10-Ks, Form 10-Qs and Form 8-Ks, including the Annual Form. Report on Form 10-K for the year ending December 31, 2021, quarterly report on Form 10-Q for the quarter ending September 30, 2022 and future SEC filings. These reports and files are available at www.sec.gov and are available for free download, shortly after these reports have been filed with the Securities and Exchange Commission or filed with the SEC, on “Investors” – “SEC Files” – “All SEC Files. Page from our website at www.180lifesciences.com. All subsequent written and oral forward-looking statements regarding the Company, the results of the results of the Company’s clinical trials and studies or other matters and attributable to the Company or anyone acting on its behalf are expressly qualified in their entirety by the cautionary statements above. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date they are made, including the forward-looking statements contained in this press release, which are made only as of the date of this release. 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 publicly disclose any updates or revisions of any forward-looking statement to reflect any change in its expectations or any change in events, conditions or circumstances on which such statement is based, except as otherwise provided by law.
180 life sciences companies