OPN1MW

First Cannabidiol drug formulation from partnership to enter clinical studies in 2024 February 15, 2024 (COPENHAGEN, Denmark). Zerion Pharma A/S (“ZERION”) today announces an exclusive partnership with dsm-firmenich to take advantage of ZERION’s expertise and its Dispersome® technology for improving the bioavailability of cannabinoids. Improvements in bioavailability of cannabinoids can open the way for broadly applying these compounds for medical and nutritional purposes via the oral route. dsm-firmenich and ZERION have worked together since 2022 to develop improved cannabinoid products of high quality that can provide meaningful and proven health benefits to patients with various diseases. The collaboration has now resulted in formulations of Cannabidiol (CBD) with improved solubility and bioavailability compared to the crystalline material, and which are expected to match or surpass existing formulations of CBD. The quality and characteristics of the new CBD formulations make them candidates to become best-in-class materials in a variety of indications where CBD is thought to have a positive effect, such as severe pain, inflammation disorders, depression, and anxiety. dsm-firmenich is planning to conduct a clinical pharmacokinetic evaluation of the improved CBD formulations in 2024. Upon successful completion of the clinical study, the new CBD Dispersome® intermediate product will be made available to the global pharmaceutical industry engaged in developing effective CBD containing drug products under partnerships with dsm-firmenich. “We are extremely happy to have partnered with dsm-firmenich that we consider a global leader in the development of novel and improved cannabinoid products. We are therefore proud to announce this partnership that has already resulted in formulations with significant improvement in CBD solubility. To me, this is a clear recognition and evidence of ZERION’s formulation expertise and the game-changing potential of our technology platform”, says Ole Wiborg, CEO of ZERION. About Zerion Pharma A/S ZERION develops its own proprietary drug formulations and offers its Dispersome® technology platform to established pharma companies as a means to solve their challenging drug solubility problems. By applying ZERION’s technology, the solubility of poorly soluble compounds may be greatly enhanced, which improves their oral bioavailability and thereby therapeutic outcomes for the patients. ZERION was established in 2019 as a spin-out from the University of Copenhagen based on almost a decade of research. About dsm-firmenich As innovators in nutrition, health, and beauty, dsm-firmenich reinvents, manufactures, and combines vital nutrients, flavors, and fragrances for the world’s growing population to thrive. With our comprehensive range of solutions, with natural and renewable ingredients and renowned science and technology capabilities, we work to create what is essential for life, desirable for consumers, and more sustainable for the planet. dsm-firmenich is a Swiss-Dutch company, listed on the Euronext Amsterdam, with operations in almost 60 countries and revenues of more than €12 billion. With a diverse, worldwide team of nearly 30,000 employees, we bring progress to life™ every day, everywhere, for billions of people. For more information, please visit or contact: Ole Wiborg, CEO Mobile: +45 40 96 80 18 E-mail: info@zerion.eu Follow us on: LinkedIn

New CEO Reinvigorates Organizational Focus and Strategic Discipline; Washington D.C. Making Headway on Federal CBD Regulatory Framework LOUISVILLE, Colo., Nov. 9, 2023 /PRNewswire/ - (TSX: CWEB) (OTCQX: CWBHF), Charlotte's Web Holdings, Inc. ("Charlotte's Web" or the "Company"), the market leader in full spectrum hemp extract wellness products, today reported financial results for the third quarter ended September 30, 2023. CEO Appointment Signals Strategic Changes On September 13, 2023, Charlotte's Web appointed Bill Morachnick, Chief Executive Officer of the Company. Mr. Morachnick is an accomplished executive with a track record of building premium, differentiated products and brands. He brings an operational and data-driven mindset fixated on growth through the integration of marketing, sales, innovation and technology, with a consumer-centric focus. "Since I joined Charlotte's Web in the late third quarter, I have been truly impressed by the talent, passion, and scientific expertise within the company," stated Bill Morachnick, the CEO of Charlotte's Web. "Following less-than-satisfactory third-quarter revenue, we have quickly mobilized a decisive action plan aimed at streamlining the organization to restore growth. We have revamped both our commercial and IT departments and are in the process of upgrading our operational platforms. Our ultimate goal with these initiatives is to elevate and fully monetize the consumer e-commerce experience, leading with data as a guidepost." Mr. Morachnick has identified three specific areas of opportunity to simplify, focus and sharpen the corporate strategy for long-term growth. First, rapid improvement of the Company's e-commerce platform and performance; second, a holistic integration of the Company's information technology infrastructure to support the company's goals; and third, refreshing the brand and integrated consumer marketing strategies. Regulatory Update On September 19, 2023, Charlotte's Web announced its founding membership in ONE HEMP, a coalition comprised of top CBD industry stakeholders to support Congress and the U.S. Food and Drug Administration (FDA) through a science and data-backed approach to arrive at sensible dietary supplement regulation. In November, ONE HEMP secured a forthcoming December 6th briefing on Capitol Hill. "It has been five years since the 2018 Farm Bill, and it has been imperative to take a bold industry-leading approach. Together with the united front of CBD leaders behind ONE HEMP, this approach is proving successful in this milestone moment," said Jared Stanley, Co-Founder and Chief Commercial Officer of Charlotte's Web. "ONE HEMP's engagement with legislative stakeholders to further regulatory clarity and stability for the CBD market demands swift and consistent action to designate CBD products as dietary supplements. We're not taking our foot off the pedal until we bring this over the finish line." ONE HEMP engaged with Congress and the FDA with an aligned industry voice through an RFI (Request for Information) response to the House and Senate committees of jurisdiction. The submission included a landmark study determining potential upper oral intake limits for safe CBD usage by consumers. Recommendations were also provided to help inform legislators and regulators as they determine manufacturing and labeling requirements for supplement products containing CBD. Progress has been encouraging surrounding The Hemp Derived Consumer Protection and Market Stabilization Act of 2023, (bill H.R. 1629) which aims to regulate hemp extract products under the dietary supplement regulatory framework. Business Review In early 2023, Charlotte's Web initiated a plan to move the production of topical products in-house. This was followed by a decision to also bring gummy production internally, and in the third quarter construction began with a modest capital expenditure. On-site manufacturing better utilizes the Company's existing Louisville production facility, improving gross margins through increased fixed cost operating leverage. The initiative aligns with the Company's ongoing efforts to improve overall operating efficiencies. "We continuously evaluate opportunities to strengthen margins through improved operating efficiencies and moved ahead with strategic optimizations in 2023 to bring the production of our topicals and gummies on-site," said Jessica Saxton, Chief Financial Officer of Charlotte's Web. "Gummies represents the largest sales volumes in our business and insourcing will improve capacity utilization and fixed cost leverage, while also optimizing production and supporting long-term operating margins. We calculate the payback period to be highly favorable, requiring only a modest increase in capital expenditure. In addition, internalizing production will also benefit our R&D, accelerating innovations and speed to market." Professional Sports League Leadership Charlotte's Web's partnership with Major League Baseball© has resulted in millions of impressions. MLB delivered over 174 million digital impressions in Q3 alone and as a result, for the month of September the Company's website experienced a 38% lift in total sessions. Charlotte's Web activated additional digital media and on-site product placement with MLB during the postseason and World Series. The Company's NSF certified for Sport® products have received placement in every MLB© playoff team's dugout, bullpen, and clubhouse throughout the postseason. Following its collaborations with Major League Baseball and Angel City Football Club in 2022, Charlotte's Web expanded its leadership in professional sports through a partnership with the Premier Lacrosse League (PLL). This partnership further cements Charlotte's Web as a CBD first-mover in the professional sports industry, with its broad-spectrum CBD NSF certified for Sport®. Through these partnerships, Charlotte's Web has gained significant exposure through consistent brand presence with national broadcast networks such as ABC, ESPN and MLB Network, brand ambassadors, and social media. The Company's partnership as the official CBD of the PLL has provided more than 65 million social logo impressions and over 837 million projected broadcast impressions since the inception of the partnership, representing over $1.1 million in broadcast media value. PLL has over 200,000 viewers per game and 1.5 million followers on social media. The Company is optimistic about the value the partnership can bring in 2024. DeFloria Update Charlotte's Web expanded into broader Botanical Wellness in 2023 through the formation of DeFloria LLC (see April 6, 2023 press release), with a subsidiary of British American Tobacco PLC (LSE: BATS andNYSE: BTI), and AJNA BioSciences PBC, a botanical drug development company. DeFloria was established to pursue a botanical investigational new drug ("IND") through the FDA drug development pathway for a botanical drug to target a neurological condition. During the third quarter, DeFloria initiated a Phase 1 clinical trial with Nucleus Networks in Brisbane, Australia. In 2024, and upon completion of Phase 1, DeFloria expects to file its IND with the FDA and commence Phase 2 clinical trials. Financial Review The following table sets forth selected financial information for the periods indicated. Consolidated net revenue for the third quarter ended September 30, 2023, was $14.3 million, a decrease from $17.0 million in the third quarter of 2022. CBD product sales year-to-date remain below expectations due to ongoing headwinds in the overall CBD category, including regulatory ambiguities at the federal and state levels, associated customer and consumer confusion, and competitive crowding and pricing pressures. The Company believes that continued positive legislative progress in Washington D.C. for the regulation of CBD will increase incremental consumer interest and confidence as well as unlock opportunities to distribute ingestible products through the mass retailer channel. Gross profit was $7.9 million, or 55.5% of revenue, as compared to gross profit of $8.9 million, or 52.5% of revenue, in the third quarter of 2022. The gross margin improvement was primarily driven by supply chain efficiencies within the quarter. Direct-to-consumer ("DTC") net revenue through the Company's webstore was $9.4 million, as compared to $11.8 million in Q3 2022. The lower e-commerce sales were primarily due to lower organic traffic and consumer acquisition. Through a recent corporate reorganization, management is optimizing the effectiveness in this important channel through a new platform holistically integrated with marketing to improve the consumer experience. External resources have also been contracted to support improved traffic and conversion. Business-to-business ("B2B") retail net revenue was $4.9 million, as compared to $5.2 million in Q3 2022. The decrease was primarily due to some of the Company's retail customers exiting the CBD category or closing retail locations over the past year. Despite some retailers consolidating the size of their in-store CBD category over the past two years, Charlotte's Web has increased the number of retail store locations offering its products in 2023. The Company recently partnered with Presence brokerage to accelerate future distribution and execution within the Natural channel. Presence is the largest brokerage within the Natural channel and brings experience partnering in the CBD category. For 2023, Charlotte's Web had category-leading distribution gains in the Natural Products Retail channel, as measured by All Commodity Volume (ACV), which is the total sales volume of all products sold in the market. SG&A Expenses Total selling, general and administrative ("SG&A") expenses in the quarter were $19.9 million, a 31.8% increase from $15.1 million, excluding a $4.1 million employee retention tax credit ("ERC") in Q3 2022. The increased SG&A includes the amortization of the MLB license and media rights assets of $2.9 million, which were not present in the comparable period last year. Excluding these MLB related expenses, SG&A increased $1.9 million, or 12.6%, year-over-year, driven by timing between quarters. For the nine months ended September 30, 2023, SG&A expenses were approximately $57.1 million in 2023 and included $6.8 million expenses related to the MLB partnership. This compares to $52.7 million for the first nine months of 2022, excluding the $4.1 million ERC in Q3 2022, and did not have MLB related expenses. Net Income and Adjusted EBITDA1 Charlotte's Web reported a net loss of $15.2 million, or ($0.10) per share basic and diluted, which included $2.9 million of expenses related to MLB in Q3 2023. This compares to a net loss of $7.6 million, or ($0.05) per share basic and diluted, in Q3 2022, which included the $4.1 million ERC. Q3 2023 and Q3 2022 both included a non-cash loss in fair market value of the Company's derivative instruments in the amount of $4.0 million. Adjusted EBITDA1 loss for the third quarter of 2023 was $6.4 million, compared to Adjusted EBITDA of $1.2 million in the third quarter of 2022. Balance Sheet and Cash Flow Net cash used for operations, for the three months ended September 30, 2023, was $7.8 million and included cash paid to MLB regarding the license and media rights assets of $2.0 million. "Of $10.7 million net cash used in the third quarter, $2.6 million was related to capital expenditures related to production insourcing, $2.0 million for MLB licensing fees, and $2.4 million in annual insurance payments. Excluding these items, our cash burn was approximately $3.7 million for the quarter," said Ms. Saxton. "We continue to take actions to reduce cash burn to ensure that our cash balance of $51.0 million at quarter end continues to provide sufficient working capital." Net cash used for operations in the nine months ended September 30 was $12.8 million and $2.6 million in 2023 and 2022, respectively. The Company's cash and working capital as of September 30, 2023, were $51.0 million and $59.0 million respectively, compared to $67.0 million and $82.3 million on December 31, 2022, respectively. Consolidated Financial Statements and Management's Discussion and Analysis The Company's audited consolidated financial statements and accompanying notes for the three and nine month periods ended September 30, 2023, and 2022 and related management's discussion and analysis of financial condition and results of operations ("MD&A"), are reported in the Company's 10-Q filing on the Securities and Exchange Commission website at and on SEDAR at and will be available on the Investor Relations section of the Company's website at . Conference Call Management will host a conference call to discuss the Company's 2023 third quarter at 11:00 A.M. ET on November 9, 2023. There are three ways to join the call: Register and enter your phone number at to receive an instant automated call back, or Dial 1-416-764-8659 or 1-888-664-6392 approximately 10 minutes before the conference call and provide conference call ID number 81041541, or Listen to the live webcast online. Earnings Call Replay A recording of the call will be available through November 16, 2023. To listen to a replay of the earnings call please dial 1-416-764-8677 or 1-888-390-0541 and provide conference replay ID 041541#. A webcast of the call will also be accessible through the investor relations section of the Company's website for an extended period of time. Subscribe to Charlotte's Web investor news. About Charlotte's Web Holdings, Inc. Charlotte's Web Holdings, Inc., a Certified B Corporation headquartered in Louisville, Colorado, is the market leader in innovative hemp extract wellness products under a family of brands that includes Charlotte's Web™, ReCreate™, CBD Medic™, and CBD Clinic™. Charlotte's Web whole-plant CBD extracts come in full-spectrum and broad-spectrum options, including ReCreate™ by Charlotte's Web, broad-spectrum CBD certified NSF for Sport®. ReCreate is the official CBD of Major League Baseball©, Angel City Football Club and the Premier Lacrosse League. Charlotte's Web branded premium quality products start with proprietary hemp genetics that are North American farm-grown using organic and regenerative cultivation practices. The Company's hemp extracts have naturally occurring botanical compounds including cannabidiol ("CBD"), CBC, CBG, terpenes, flavonoids, and other beneficial compounds. Charlotte's Web product categories include CBD oil tinctures (liquid products) CBD gummies (sleep, calming, exercise recovery, immunity), CBD capsules, CBD topical creams and lotions, as well as CBD pet products for dogs. Through its substantially vertically integrated business model, Charlotte's Web maintains stringent control over product quality and consistency with analytic testing from soil to shelf for quality assurance. Charlotte's Web products are distributed to retailers and health care practitioners throughout the U.S.A, and online through the Company's website at . Shares of Charlotte's Web trade on the Toronto Stock Exchange (TSX) under the symbol "CWEB" and are quoted in U.S. Dollars in the United States on the OTCQX under the symbol "CWBHF". As of September 30, 2023, Charlotte's Web had 153,779,856 Common Shares outstanding. Subscribe to Charlotte's Web investor news. © Major League Baseball trademarks and copyrights are used with permission of Major League Baseball. Visit MLB.com. Forward-Looking Information Certain information provided herein constitutes forward-looking statements or information (collectively, "forward-looking statements") within the meaning of applicable securities laws. Forward-looking statements are typically identified by words such as "may", "will", "should", "could", "anticipate", "expect", "project", "estimate", "forecast", "plan", "intend", "target", "believe" and similar words suggesting future outcomes or statements regarding an outlook. Forward-looking statements are not guarantees of future performance and readers are cautioned against placing undue reliance on forward-looking statements. By their nature, these statements involve a variety of assumptions, known and unknown risks and uncertainties, and other factors which may cause actual results, levels of activity, and achievements to differ materially from those expressed or implied by such statements. The forward-looking statements contained in this press release are based on certain assumptions and analysis by management of the Company in light of its experience and perception of historical trends, current conditions and expected future development and other factors that it believes are appropriate and reasonable. Specifically, this press release contains forward-looking statements relating to, but not limited to: organizational changes and operational platform upgrades, and the impact of these initiatives on revenue and e-commerce monetization; regulatory developments and the impact of developments on both consumer action and the Company's opportunities and operations; activities relating to, and sponsorship of, legislation to advance regulatory framework; the impact of insourcing on operating margins, capital expenditures and R&D; DeFloria's anticipated progress and activities in 2024; anticipated consumer trends and corresponding product innovation; anticipated future financial results; the impact of the Company's partnership with the MLB and PLL on the Company's exposure and sales; the impact of the Company's new distribution partners on sales; the Company's ability to increase online traffic and demographic exposure through new products and marketing; and the impact of certain activities on the Company's business and financial condition and anticipated trajectory. The material factors and assumptions used to develop the forward-looking statements herein include, but are not limited to: regulatory regime changes; anticipated product development and sales; the success of sales and marketing activities; product development and production expectations; outcomes from R&D activities; the Company's ability to deal with adverse growing conditions in a timely and cost-effective manner; the availability of qualified and cost-effective human resources; compliance with contractual and regulatory obligations and requirements; availability of adequate liquidity and capital to support operations and business plans; and expectations around consumer product demand. In addition, the forward-looking statements are subject to risks and uncertainties pertaining to, among other things: supply and distribution chains; the market for the Company's products; revenue fluctuations; regulatory changes; loss of customers and retail partners; retention and availability of talent; competing products; share price volatility; loss of proprietary information; product acceptance; internet and system infrastructure functionality; information technology security; available capital to fund operations and business plans; crop risk; economic and political considerations; and including but not limited to those risks and uncertainties discussed under the heading "Risk Factors" in the Company's Annual Report on Form 10-K for the year ending December 31, 2022 and other risk factors contained in other filings with the Securities and Exchange Commission available on and filings with Canadian securities regulatory authorities available on . The impact of any one risk, uncertainty, or factor on a particular forward-looking statement is not determinable with certainty as these are interdependent, and the Company's future course of action depends on management's assessment of all information available at the relevant time. Any forward-looking statement in this press release is based only on information currently available to the Company and speaks only as of the date on which it is made. Except as required by applicable law, the Company assumes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. All forward-looking statements, whether written or oral, attributable to the Company or persons acting on the Company's behalf, are expressly qualified in their entirety by these cautionary statements. (1) Non-GAAP Measures: The press release contains non-GAAP measures, including EBITDA and Adjusted EBITDA. Please refer to the section in the tables captioned "Non-GAAP Measures" below for additional information and a reconciliation to GAAP for all Non-GAAP metrics. (1) Non-GAAP Measures – EBITDA and Adjusted EBITDA Earnings before interest, taxes, depreciation, and amortization ("EBITDA") is not a recognized performance measure under U.S. GAAP. The term EBITDA consists of net loss and excludes interest, taxes, depreciation, and amortization. Adjusted EBITDA also excludes other non-cash items such as changes in fair value of financial instruments (Mark-to-Market), Share-based compensation, and impairment of assets. These non-GAAP financial measures should be considered supplemental to, and not a substitute for, our reported financial results prepared in accordance with GAAP. The non-GAAP financials measures do not have a standardized meaning prescribed under U.S. GAAP and therefore may not be comparable to similar measures presented by other issuers. The primary purpose of using non-GAAP financial measures is to provide supplemental information that we believe may be useful to investors and to enable investors to evaluate our results in the same way we do. We also present the non-GAAP financial measures because we believe they assist investors in comparing our performance across reporting periods on a consistent basis, as well as comparing our results against the results of other companies, by excluding items that we do not believe are indicative of our core operating performance. Specifically, we use these non-GAAP measures as measures of operating performance; to prepare our annual operating budget; to allocate resources to enhance the financial performance of our business; to evaluate the effectiveness of our business strategies; to provide consistency and comparability with past financial performance; to facilitate a comparison of our results with those of other companies, many of which use similar non-GAAP financial measures to supplement their GAAP results; and in communications with our board of directors concerning our financial performance. Investors should be aware, however, that not all companies define these non-GAAP measures consistently. Adjusted EBITDA for the three and nine months ended September 30, 2023, and 2022 is as follows: Certain prior year amounts in the table above have been conformed to the current year presentation in accordance with how the Company is defining the EBITDA and Adjusted EBITDA calculation on September 30, 2023 SOURCE Charlotte's Web Holdings, Inc.

PALO ALTO, Calif., Aug. 07, 2023 (GLOBE NEWSWIRE) -- 180 Life Sciences Corp. (NASDAQ: ATNF) (“180 Life Sciences” or the “Company”), today announced that an agreement has been reached with Prof. Avi Domb of the Hebrew University, School of Pharmacy, and with Prof. Elyad Davidson, of Hadassah Hospital, to perform a clinical pharmacology (“Pharmacokinetic” or “PK”) study of the uptake of cannabidiol (CBD) in a formulation which can be delivered as a pill orally. The PK study will seek to determine how much CBD is taken up into the blood of volunteers. While CBD preparations have previously been approved by the U.S. Food and Drug Administration (FDA) for rare forms of childhood epilepsy, a major problem in working with CBD is its low and unpredictable and variable uptake following the most convenient delivery form, by mouth, as CBD in oil. This has hampered progress and clinical trials seeking potential uses for CBD, such as for the treatment of pain, post-traumatic stress disorder (PTSD), head trauma, and more, where reports have suggested the possibility of benefits. To help try to solve this problem, Prof. Domb and colleagues have developed “ProNanoLipospheres” (PNL), a mixture of components available over-the-counter, which form little droplets and have been shown to be absorbed from the gastrointestinal tract into blood. The dosage form has been shown in preliminary testing in rats to increase uptake of CBD, decrease absorption variability and enable controlled release pharmacokinetics. Based on these animal results, a human PK study is being designed to test whether the formulation increases CBD blood levels after oral administration. This PK study will be performed at Hadassah Hospital executed by an experienced team under the supervision of Prof. Davidson and Prof. Domb, in collaboration with 180 Life Sciences. The currently available plant-based CBD formulations may contain up to 100 compounds and not just the CBD molecule. From prior work over several years with Prof. Raphael Mechoulam of Hebrew University, who discovered the human endocannabinoid system, a number of synthetic CBD compounds were developed, that in animal models exhibited both anti-inflammatory and analgesic properties. Prof. Mechoulam recently passed away but leaves a legacy that may provide substantial clinical benefit to patients suffering from pain. “We believe that the new pill formulation has the potential to dramatically improve the availability and absorption of CBD taken orally as a pill, and plan to facilitate clinical studies to test this,” said Prof. Sir Marc Feldmann, Executive Co-Chairman of 180 Life Sciences, who continued, “If successful, we believe that this may significantly expand the use of CBD and derivatives and may permit their use in multiple conditions including most importantly pain (a huge unmet need where there are few safe drugs), anxiety and, as discussed below, weight management. Recent human studies have demonstrated that CBD can improve post-operative pain and might decrease opioid consumption, an important goal(1). This is an exciting prospect and Prof. Domb’s team has a track record in formulating medications for therapeutic use.” ”We are delighted to collaborate with the team at 180 Life Sciences, including Prof. Marc Feldmann, who pioneered the development of anti-Tumor Necrosis Factor (TNF) antibodies for rheumatoid arthritis,” said Prof. Domb of the Hebrew University, School of Pharmacy. “Ultimately, our team’s formulation may use pure synthetic CBD, which we believe in many countries is not subject to controlled substance regulations, but in other countries may be subject to local regulations, and which we believe will be convenient to administer”, continued Prof. Domb. “We are excited to be working with talented cannabis research pioneers such as Prof. Domb,” said Dr. James Woody, CEO of 180 Life Sciences, who continued, “We believe that this work could potentially validate the effectiveness of solid PNL, and if so, could potentially open up the door to many new uses to be considered and researched. These may include combination therapy including anti-inflammatory biologics, together with the analgesic properties of CBD when administered in appropriate doses with this potential new convenient pill formulation. In addition, considering our recent provisional patent filing describing the potential combination treatment of using CBD with GLP-1 agonists to suppress appetite, delivery of CBD in a solid pill formula for obesity and weight management may provide a convenient therapy. 180 Life Sciences has filed patents to protect its discoveries. The Company’s focus now is on our core assets that are in the clinic, which is comprised of our anti-TNF program for Dupuytren’s disease (fibrosis of the hand) and delirium, and now CBD." (1) Talk by Michael J. Alaia, MD, FAAOS concerning the efficacy of an orally absorbed CBD tablet for postoperative pain relief following rotator cuff surgery. Presented at the 2022 American Academy of Orthopaedic Surgeons Annual Meeting. About 180 Life Sciences Corp. 180 Life Sciences Corp. is a clinical stage biotechnology company focused on the development of therapeutics for unmet medical needs in chronic pain, inflammation and fibrosis by employing innovative research, and, where appropriate, combination therapy. The Company’s current primary focus is a novel program to treat several inflammatory disorders 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, risks regarding the outcome of the pharmacokinetics (PK) study discussed above, the timing and costs thereof, and the ability to obtain sufficient participants; our ability to commercialize PNL and our other drug candidates, if proven successful for treatment in trials; risks regarding whether the administrative processes required for the issuance of patents will be completed in a timely manner or at all, whether patents, if issued, will provide sufficient protection and market exclusivity for the Company, whether any patents held by the Company may be challenged, invalidated, infringed or circumvented by third parties; events that could interfere with the continued validity or enforceability of a patent; the Company’s ability generally to maintain adequate patent protection and successfully enforce patent claims against third parties; the timing of, outcome of, and results of, clinical trials statements regarding the timing of our planned marketing authorization application (MAA) submission to the UK Medicines and Healthcare products Regulatory Agency (MHRA) and our planned New Drug Application submission (NDA) to the U.S. Food and Drug Administration (FDA), our ability to obtain approval and acceptance thereof, the willingness of MHRA to review such MAA and the FDA to review such NDA, and our ability to address outstanding comments and questions from the MHRA and FDA; statements about the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results; the uncertainties associated with the clinical development and regulatory approval of 180 Life Sciences’ drug candidates, including potential delays in the enrollment and completion of clinical trials, the costs thereof, closures of such trials prior to enrolling sufficient participants in connection therewith, issues raised by the U.S. Food and Drug Administration (FDA), the MHRA and the European Medicines Agency (EMA); the ability of the Company to persuade regulators that chosen endpoints do not require further validation; timing and costs to complete required studies and trials, and timing to obtain governmental approvals; the accuracy of simulations and the ability to reproduce the outcome of such simulations in real world trials; 180 Life Sciences’ reliance on third parties to conduct its clinical trials, enroll patients, and manufacture its preclinical and clinical drug supplies; the ability to come to mutually agreeable terms with such third parties and partners, and the terms of such agreements; estimates of patient populations for 180 Life Sciences planned products; 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, increases in interest rates which may make borrowing more expensive and increased inflation which may negatively affect costs, expenses and returns; 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 are not predictive of future results or 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’s securities 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 the Company’s 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, and dilution caused thereby; and the effect of rising interest rates and inflation, economic downturns and recessions, declines in economic activity or global conflicts. 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, and including the Annual Report on Form 10-K for the year ended December 31, 2022, and Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, and future SEC filings. These reports and filings are available at and are available for download, free of charge, soon after such reports are filed with or furnished to the SEC, on the “Investors”, “SEC Filings”, “All SEC Filings” page of our website at 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 Jassad@180lifesciences.com