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PALO ALTO, Calif., January 17, 2023 (GLOBE NEWSWIRE) — 180 Life Sciences Corporation (NASDAQ: ATNF) (“180 Life Sciences” or the “Company”) today announced that it has engaged Kinexum, a strategic advisory firm, in the submission of a Marketing Authorization Application (MAA) for adalimumab for the treatment of advanced disease announced that it had Early Dupuytren’s disease. The MAA is submitted to the UK Medicines and Healthcare Products Regulatory Authority (MHRA or Authority). As part of the application, we expect to request a Conditional Marketing Authorization (CMA). This assures agencies that long-term results data will be available soon. Including costs associated with the Kinexam agreement, the company expects to spend approximately $900,000 to $1 million in aggregate over the next three quarters on MHRA filings and other regulatory preparation-related activities.
About 180 Life Science Company
180 Life Sciences Corp. is a clinical-stage biotechnology company that advances breakthrough research into clinical programs that seek to address major unmet medical needs. The company’s focus is on new programs to treat several inflammatory diseases using anti-TNF (tumor necrosis factor).
About Kinexum (www.kinexum.com)
Since 2003, Kinexum has been a leader in assisting clients through the regulatory, clinical and product development processes for a wide range of therapeutic areas and modalities, from initial regulatory approaches to post-market negotiations.
Forward-Looking Statements
This press release contains the provisions of the Private Securities Litigation Reform Act of 1995 (the “Activity”). “expect”, “estimate”, “plan”, “budget”, “forecast”, “expect”, “intend”, “plan”, “could”, “will” , “could”, “should” and other words such as “believe”, “predict”, “could”, “continue” and similar expressions do not express such forward-looking statements. is intended to identify statements about These forward-looking statements involve significant risks and uncertainties that could cause actual results to differ materially from expected results; statements should not be relied upon. These forward-looking statements and the factors that could cause such differences include, but are not limited to, the timing of the planned submission of a Marketing Authorization Application (MAA) to the UK Medicines and Healthcare Products Regulatory Agency (MHRA); including, but not limited to, statements regarding our ability to obtain its conditional or final approval, MHRA’s willingness to accept or consider such MAA, and our ability to address outstanding comments and questions from MHRA. Statements regarding the ability of our clinical trials to demonstrate the safety and efficacy of our product candidates and other positive results. uncertainties associated with the clinical development and regulatory approval of 180 Life Sciences’ drug candidates; This includes potential delays in registration and completion of clinical trials, issues raised by the MHRA, the US Food and Drug Administration (FDA), or other regulatory agencies. the country or region; the company’s ability to persuade such regulatory authorities that the endpoint selected does not require further validation; the timing of completing the required studies and trials, and obtaining government approval. Accuracy of simulations and the ability to reproduce the results of such simulations in real-world tests. 180 Life Sciences’ reliance on third parties to conduct clinical trials, enroll patients, and manufacture preclinical and clinical medicines; Mutually agreeable terms with such third parties and partners, and the ability to enter into such terms. Patient population estimates for 180 life sciences planning products. Unexpected adverse side effects or inadequate therapeutic efficacy of drug candidates that may limit approval and/or commercialization or lead to recalls or product liability claims; product development activities of 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 The timing of submissions, the timing of government reviews, and the outcome of proposed investigational new drug (IND) submissions for drug candidates. Current negative operating cash flow and need for additional funds to fund the operating plan. Additional financing terms that can be highly dilutive and can include onerous terms, higher interest rates that can make borrowing more expensive and adversely affect costs, expenses and revenues Possible increase in inflation. Statement of expectations regarding future agreements for material supply, licensing and product commercialization. Availability and cost of materials required for testing. The risk that early drug results may not predict future results or 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. This includes the uncertainty of clinical success and the uncertainty of obtaining regulatory approval. uncertainty of commercial success; risks inherent in early-stage drug development, including demonstration of efficacy; Development time/cost and regulatory approval process. Clinical trial progress. our ability to find and enter into agreements with potential partners; our ability to attract and retain key talent; changes in market and economic conditions; Our ability to produce acceptable batches of future products in sufficient quantity. unexpected manufacturing defects; manufacturing problems and delays; Competition, such as technological advances, new products, and patents issued by competitors. patent challenges; product efficacy or safety concerns leading to product recalls or regulatory action; Changes in purchaser behavior and spending patterns for healthcare products and services. changes in applicable laws and regulations, including global healthcare reform; expectations regarding future performance, growth and anticipated acquisitions; Continued listing of our securities on the Nasdaq stock market. expectations regarding our capital, resources and ownership structure; expectations regarding future performance, growth and anticipated acquisitions; the company’s ability to execute new drug development and marketing plans, and the timing and cost of these development programs; Market size estimates for potential pharmaceuticals. the outcome of any current litigation involving us; potential future litigation relating to the validity or enforceability of us or our intellectual property; global economic conditions; geopolitical events and regulatory changes; expectations, development plans and expected timelines for our drug candidates, pipelines and programs, including collaborations with third parties; access to additional funding and the potential shortage of such funding; our ability to raise funding in the future and the terms of such funding; The impact of rising interest rates and inflation, recession and recession. These risk factors and others are included from time to time in the Company’s filings with the Securities and Exchange Commission. This includes, but is not limited to, Form 10-K, Form 10-Q, and Form 8-K. Reporting on Form 10-K for the year ended December 31, 2021 and quarterly reporting 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 free of charge from Investors, SEC Filings and All SEC Filings immediately after such report is filed or filed with the SEC. You can download it at page www.180lifesciences.com. All subsequent written and oral forward-looking statements regarding the Company, the results of our clinical trials and studies, or any other matter arising from the Company or any person acting on its behalf. Statements about are expressly qualified in their entirety by the above notice. Readers are cautioned not to place undue reliance on forward-looking statements, including those contained in this press release, which speak only as of the date they are made. We cannot guarantee future results, levels of activity, performance or achievements. Therefore, undue reliance should not be placed on these forward-looking statements. We undertake no obligation to publicly release updates or revisions to any forward-looking statements, nor will we accept them, except as follows: In other cases as stipulated by law.
Investor:
Jason Assad
Investor Relations Director
180 Life Sciences Corporation
Jason@180lifesciences.com
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