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180 Life Sciences Announces Positive Topline Results of a Clinical Pharmacology Study Testing a New Solid Formulation of CBD with Enhanced Oral Uptake
GlobeNewswire News Room· 2024-07-30 12:00
Core Insights - 180 Life Sciences Corp. announced topline results from a clinical pharmacology study evaluating the uptake of cannabidiol (CBD) in solid formulations compared to the FDA-approved drug Epidiolex [1][2] - The study involved twelve volunteers and demonstrated that one of the solid formulations was absorbed faster and reached higher maximal levels than Epidiolex, while both formulations were well tolerated [2][3] - The development of solid formulations for CBD could enhance its clinical application for various indications, addressing the limitations of liquid formulations [4] Company Overview - 180 Life Sciences Corp. is a clinical stage biotechnology company focused on developing therapeutics for unmet medical needs in chronic pain, inflammation, and fibrosis [5] Clinical Study Details - The clinical trial was conducted in collaboration with Prof. Avi Domb and Prof. Elyad Davidson, comparing two solid formulations of CBD with Epidiolex [1][3] - The study results indicate that capsules made from one of the ProNanoLipospheres (PNL) formulations performed statistically better than Epidiolex in terms of absorption speed and maximal levels [3] - The other PNL formulation was found to be statistically equivalent to Epidiolex regarding absorption speed and maximal levels [3] Market Potential - The proprietary solid formulation for CBD delivery may provide medical professionals with expanded options for prescribing CBD in a high uptake pill format, potentially increasing market acceptance [4]
180 Life Sciences (ATNF) - 2024 Q1 - Quarterly Report
2024-05-15 21:01
PART I - FINANCIAL INFORMATION [Financial Statements](index=3&type=section&id=ITEM%201.%20Financial%20Statements) The company presents unaudited Q1 2024 financials showing a $1.1 million net loss and a going concern warning Condensed Consolidated Balance Sheet Data (Unaudited) | Account | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash | $675,977 | $1,975,799 | | Total Current Assets | $1,854,948 | $3,639,906 | | Total Assets | $3,441,740 | $5,259,476 | | Total Current Liabilities | $4,080,307 | $5,062,616 | | Total Liabilities | $4,396,206 | $5,387,209 | | Total Stockholders' Deficit | ($954,466) | ($127,733) | Condensed Consolidated Statements of Operations (Unaudited) | Account | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Total Operating Expenses | $2,092,468 | $4,803,845 | | Loss From Operations | ($2,092,468) | ($4,803,845) | | Other Income, Net | $1,022,724 | $41,767 | | Net Loss | ($1,069,744) | ($4,762,078) | | Basic and Diluted Net Loss per Share | ($1.68) | ($24.15) | Condensed Consolidated Statements of Cash Flows (Unaudited) | Cash Flow Activity | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Net Cash Used In Operating Activities | ($1,033,417) | ($3,869,891) | | Net Cash Used In Financing Activities | ($264,394) | ($469,810) | | Net Decrease In Cash | ($1,299,822) | ($4,323,926) | | Cash - End of Period | $675,977 | $2,646,184 | - The company is a clinical-stage biotech firm with R&D activities **significantly slowed or suspended** due to resource constraints[24](index=24&type=chunk) - The company is actively **evaluating strategic alternatives**, including potential mergers or asset sales, to maximize stockholder value[25](index=25&type=chunk)[145](index=145&type=chunk) - Significant losses and a **$128.4 million accumulated deficit** raise substantial doubt about the company's ability to continue as a going concern[26](index=26&type=chunk)[27](index=27&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=30&type=section&id=ITEM%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses a reduced net loss in Q1 2024 but highlights a critical financial state and exploration of strategic alternatives [Going Concern and Management Liquidity Plans](index=33&type=section&id=Going%20Concern%20and%20Management%20Liquidity%20Plans) The company faces a going concern issue with cash expected to last only through October 2024 despite recent funding - As of March 31, 2024, the company had an **accumulated deficit of $128.4 million** and a working capital deficit of $2.2 million[135](index=135&type=chunk) - The company has a **minimum monthly cash requirement of approximately $300,000** to support operations[137](index=137&type=chunk) - Following insurance reimbursements, the company had approximately **$1.5 million in cash as of May 13, 2024**, expected to fund operations through October 2024[170](index=170&type=chunk) [Consolidated Results of Operations](index=38&type=section&id=CONSOLIDATED%20RESULTS%20OF%20OPERATIONS) Net loss decreased 78% in Q1 2024, driven by lower operating expenses and a one-time income from forgiven liabilities Comparison of Operating Results (Q1 2024 vs. Q1 2023) | Metric | Q1 2024 | Q1 2023 | Change (%) | | :--- | :--- | :--- | :--- | | Research & Development | $365,186 | $578,309 | -37% | | General & Administrative | $1,556,740 | $4,008,852 | -61% | | Other Income, Net | $1,022,724 | $41,767 | +2,349% | | Net Loss | ($1,069,744) | ($4,762,078) | -78% | - The decrease in G&A expenses was primarily due to **reduced legal fees (~$1.3M)**, accounting/regulatory fees (~$450k), salaries (~$300k), and stock-based compensation (~$280k)[161](index=161&type=chunk) - The significant increase in Other Income is attributable to the **forgiveness of $1,039,364 in liabilities** owed to contractors for certain R&D programs[41](index=41&type=chunk)[162](index=162&type=chunk) [Liquidity and Capital Resources](index=39&type=section&id=Liquidity%20and%20Capital%20Resources) The company has severely constrained liquidity with a working capital deficit and significant future cash requirements - Cash balance **decreased from $2.0 million at year-end 2023 to $676k** at March 31, 2024, while the working capital deficit increased to $2.2 million[163](index=163&type=chunk) - Cash used in operating activities for Q1 2024 was **$1.0 million**, a significant reduction from $3.9 million in Q1 2023[164](index=164&type=chunk) - The company estimates material cash requirements of approximately **$4.1 million for 2024** and **$23.5 million for 2025 through 2028**[167](index=167&type=chunk) - In November 2023, the company amended its August 2023 offering, raising an **additional $0.8 million in net proceeds** and modifying warrant terms[176](index=176&type=chunk)[177](index=177&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=43&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, the firm is exempt from providing market risk disclosures - As a "smaller reporting company," the Company is **exempt from the requirement to provide disclosures** about market risk under Item 305(e) of Regulation S-K[183](index=183&type=chunk) [Controls and Procedures](index=43&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were ineffective due to a material weakness in financial reporting - The principal executive and financial officers concluded that **disclosure controls and procedures were not effective** as of March 31, 2024[186](index=186&type=chunk) - A **material weakness** was identified from the misclassification of a forgiven liability as a reduction to R&D expense instead of an increase in Other Income[186](index=186&type=chunk) - Management's remediation plan includes implementing an **additional layer of technical review** for significant, non-routine entries[190](index=190&type=chunk) PART II - OTHER INFORMATION [Legal Proceedings](index=46&type=section&id=Item%201.%20Legal%20Proceedings.) The company is involved in several legal proceedings but does not expect a material adverse financial impact - The company is party to various legal proceedings, which are described in detail in **Note 8 of the financial statements**[195](index=195&type=chunk) - Management believes the ultimate resolution of current legal proceedings **will not have a material adverse effect** on the company's financial position, though the outcome is uncertain[194](index=194&type=chunk)[195](index=195&type=chunk) [Risk Factors](index=46&type=section&id=Item%201A.%20Risk%20Factors.) The company faces a significant risk of delisting from Nasdaq due to non-compliance with listing standards - The company is **not in compliance with Nasdaq's minimum stockholders' equity requirement** of $2.5 million[200](index=200&type=chunk) - On May 14, 2024, the company received a **delist determination letter from Nasdaq** for failing to regain compliance by the May 13, 2024 deadline[205](index=205&type=chunk) - The company **intends to request a hearing with the Nasdaq Hearings Panel** to appeal the delisting, which is expected to stay the suspension of trading[206](index=206&type=chunk) - The company is also **non-compliant with Nasdaq's audit committee requirement** of at least three independent directors[208](index=208&type=chunk)[211](index=211&type=chunk) - **Delisting from Nasdaq** could make trading the company's securities difficult and impair the ability to raise capital[212](index=212&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=50&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds.) No unregistered sales of equity securities or issuer repurchases occurred during the quarter - There were **no unregistered sales of equity securities** during the quarter ended March 31, 2024, that were not previously disclosed[213](index=213&type=chunk) [Other Information](index=50&type=section&id=Item%205.%20Other%20Information.) No directors or officers adopted or terminated Rule 10b5-1 trading plans during the quarter - **No directors or officers adopted or terminated a Rule 10b5-1 trading plan** or other trading arrangement during the quarter ended March 31, 2024[214](index=214&type=chunk) [Exhibits](index=51&type=section&id=Item%206.%20Exhibits.) This section lists required Sarbanes-Oxley certifications and other exhibits filed with the Form 10-Q - The report includes required certifications from the Principal Executive Officer and Principal Accounting Officer under **Sections 302 and 906 of the Sarbanes-Oxley Act**[216](index=216&type=chunk)[217](index=217&type=chunk)
180 Life Sciences (ATNF) - 2023 Q4 - Annual Report
2024-03-23 01:27
PART I [Item 1. Business](index=10&type=section&id=Item%201.%20Business) 180 Life Sciences is a clinical-stage biotechnology company developing therapeutics for chronic pain, inflammation, and fibrosis, with its lead Dupuytren's Contracture candidate having completed Phase 2b trials, and is exploring strategic alternatives [Company Overview and Strategy](index=13&type=section&id=Company%20Overview%20and%20Strategy) - 180 Life Sciences is a clinical-stage biotechnology company focused on developing therapeutics for unmet needs in chronic pain, inflammation, and fibrosis[50](index=50&type=chunk) - The company operates three distinct product development platforms: Anti-TNF (fibrosis), SCAs (synthetic cannabidiol analogues), and α7nAChR (alpha 7 nicotinic acetylcholine receptor)[51](index=51&type=chunk) - The lead product candidate under the anti-TNF platform has completed Phase 2b clinical trials for early-stage Dupuytren's Contracture[51](index=51&type=chunk) - Due to resource constraints, the company has suspended research and development activities for the α7nAChR platform[53](index=53&type=chunk) - The company is actively evaluating strategic alternatives to maximize shareholder value, which may include mergers, acquisitions, sale of assets, or other business combinations[54](index=54&type=chunk) [Product Development Platforms and Pipeline](index=15&type=section&id=Product%20Development%20Platforms%20and%20Pipeline) Product Development Pipeline Status | Platform | Indication | Development Phase | | :--- | :--- | :--- | | **Anti-TNF** | Dupuytren's Contracture | Phase 2b Completed | | | Frozen Shoulder | Feasibility Trial (Recruitment Closed) | | | Post-Operative Cognitive Decline (POCD) | Planned Phase 2 | | | Liver and Lung Fibrosis | Preclinical | | **SCAs** | Arthritis, Pain, Inflammation | Preclinical | | **α7nAChR** | Inflammatory Diseases | Suspended | - The Phase 2b trial for Dupuytren's Contracture met its primary endpoint of nodule hardness and secondary endpoint of nodule size with statistical significance[61](index=61&type=chunk) - The company intends to seek Conditional Marketing Authorization (CMA) in the U.K. for its Dupuytren's therapy, which will require a limited Phase 3 outcomes trial to be initiated prior to submission[62](index=62&type=chunk)[63](index=63&type=chunk) - Recruitment for the frozen shoulder feasibility trial was closed early at nine patients due to a regulatory request in the U.K. to end slow-recruiting trials, necessitating a future trial[58](index=58&type=chunk)[65](index=65&type=chunk) - The HMGB1 program, part of the Anti-TNF platform, was terminated in September 2023 to focus resources on the primary fibrosis platform[67](index=67&type=chunk) [Material Agreements](index=24&type=section&id=Material%20Agreements) - The company has key research and licensing agreements with the Hebrew University of Jerusalem (via Yissum) for its SCAs platform, involving license fees, milestone payments, and royalties[113](index=113&type=chunk)[116](index=116&type=chunk)[118](index=118&type=chunk) - Multiple research and license agreements are in place with the University of Oxford to sponsor R&D for the anti-TNF platform (Dupuytren's, frozen shoulder, fibrosis) and the SCAs platform[125](index=125&type=chunk)[130](index=130&type=chunk)[133](index=133&type=chunk) - The exclusive license agreement with Oxford for the HMGB1 molecule program was terminated on September 22, 2023, to conserve resources[145](index=145&type=chunk) - An exclusive license agreement with Stanford University is in place for the α7nAChR platform, requiring annual maintenance fees, milestone payments, and royalties[147](index=147&type=chunk)[149](index=149&type=chunk) - Consulting agreements are in place with key scientific leaders, including Prof. Jagdeep Nanchahal, Prof. Sir Marc Feldmann, and Prof. Lawrence Steinman, outlining compensation, bonuses, and service requirements[161](index=161&type=chunk)[172](index=172&type=chunk)[179](index=179&type=chunk) [Recent and Material Events](index=36&type=section&id=Recent%20and%20Material%20Events) - In October 2023, the UK's MHRA confirmed that a single Phase 3 study could be sufficient for Marketing Authorization for the Dupuytren's treatment but would not support a Conditional Marketing Authorization (CMA) based on Phase 2b data alone[187](index=187&type=chunk)[188](index=188&type=chunk) - In December 2023, the company engaged A.G.P./Alliance Global Partners to explore strategic alternatives, including potential mergers, acquisitions, or asset sales[192](index=192&type=chunk) - The company has faced multiple Nasdaq compliance issues, including failure to meet the **$1.00 minimum bid price**, shareholder approval rules, and the **$2.5 million minimum stockholders' equity requirement**[194](index=194&type=chunk)[198](index=198&type=chunk)[212](index=212&type=chunk) - A **1-for-19 reverse stock split** was effective on February 28, 2024, and on March 13, 2024, Nasdaq confirmed the company regained compliance with the minimum bid price rule[197](index=197&type=chunk) - The company owes approximately **£929,030** to the University of Oxford and is in discussions for a payment plan; Oxford has threatened legal proceedings, which could force the company to scale back operations or seek bankruptcy protection[219](index=219&type=chunk) [Competition](index=42&type=section&id=Competition) - For early-stage Dupuytren's Contracture, the company's proposed treatment has no currently approved direct competitor; existing treatments like surgery and Xiaflex target late-stage disease[227](index=227&type=chunk) - In the SCAs (cannabidiol) space, the primary competitor is Jazz Pharmaceuticals with its approved drug Epidiolex; other competitors include Cardiol Therapeutics and Zynerba Pharmaceuticals[228](index=228&type=chunk)[230](index=230&type=chunk) - For the α7nAChR platform, competition includes orally available Jak inhibitors (e.g., Xeljanz, Rinvoq) and electroceutical companies like SetPoint Medical Corporation, which are developing vagus nerve stimulation devices[233](index=233&type=chunk)[234](index=234&type=chunk) [Government Regulation](index=44&type=section&id=Government%20Regulation) - Pharmaceutical products in the U.S. are subject to extensive regulation by the FDA under the FDC Act and PHS Act, covering research, development, testing, manufacturing, and marketing[239](index=239&type=chunk)[240](index=240&type=chunk) - The drug development process typically involves preclinical testing and a three-phase clinical trial process (Phase 1, 2, 3) before submitting a New Drug Application (NDA) or Biologics License Application (BLA) to the FDA[241](index=241&type=chunk)[247](index=247&type=chunk) - In the EU and UK, medicinal products are regulated by the EMA and MHRA, respectively; the process involves submitting a Clinical Trial Application (CTA) and, for approval, a marketing authorization application through various procedures (e.g., centralized, mutual recognition)[294](index=294&type=chunk)[296](index=296&type=chunk)[301](index=301&type=chunk) - The company's SCA product candidates may be subject to regulation as controlled substances by the DEA in the U.S. and similar bodies internationally, which imposes strict registration, security, and recordkeeping requirements[287](index=287&type=chunk)[288](index=288&type=chunk) [Corporate History](index=60&type=section&id=Corporate%20History) - The company was formed as a blank check company (SPAC), KBL Merger Corp. IV, in 2016 and completed its IPO in June 2017[333](index=333&type=chunk)[334](index=334&type=chunk) - On November 6, 2020, the company completed a business combination with 180 Life Corp., which became a wholly-owned subsidiary; the combined entity was renamed 180 Life Sciences Corp[337](index=337&type=chunk)[341](index=341&type=chunk) - The company has executed two reverse stock splits: a **1-for-20 split** effective December 19, 2022, and a **1-for-19 split** effective February 28, 2024[346](index=346&type=chunk)[348](index=348&type=chunk) [Item 1A. Risk Factors](index=65&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial financial and operational risks, including significant doubt about its going concern ability, dependence on clinical trial success, intense competition, and Nasdaq listing non-compliance - The company's current cash is only sufficient to fund operations through approximately **May 2024**, raising substantial doubt about its ability to continue as a going concern; additional capital is required but may not be available on favorable terms, if at all[360](index=360&type=chunk)[364](index=364&type=chunk)[365](index=365&type=chunk) - The company is not in compliance with Nasdaq's minimum stockholders' equity requirement of **$2.5 million**, reporting a deficit as of September 30, 2023; failure to regain compliance by the May 13, 2024 deadline could result in delisting[627](index=627&type=chunk)[628](index=628&type=chunk)[633](index=633&type=chunk) - A significant financial risk arises from approximately **£929,030** owed to the University of Oxford; failure to agree on a payment plan could lead to legal action, termination of critical license agreements, and potentially force the company to seek bankruptcy protection[379](index=379&type=chunk)[380](index=380&type=chunk) - The business is highly dependent on the success of its product candidates, particularly the anti-TNF treatment for Dupuytren's Contracture; failure to successfully complete clinical development, obtain regulatory approval, or commercialize products would materially harm the business[455](index=455&type=chunk)[456](index=456&type=chunk) - The company faces intense competition from well-established companies with greater financial and technical resources, and its method-of-use patents for the anti-TNF program may not prevent competitors from using biosimilar drugs for the same indication[407](index=407&type=chunk)[408](index=408&type=chunk)[413](index=413&type=chunk) [Item 1B. Unresolved Staff Comments](index=125&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports no unresolved staff comments from the SEC - None [Item 1C. Cybersecurity](index=125&type=section&id=Item%201C.%20Cybersecurity) The company engages cybersecurity consultants, with the CFO overseeing risks and providing board updates, and reported no material incidents as of year-end 2023 - The company engages external consultants to assess and manage cybersecurity threats, including operational risks, fraud, and data privacy[677](index=677&type=chunk) - The CFO is responsible for overseeing cybersecurity risks, with the Board receiving periodic updates[680](index=680&type=chunk) - As of December 31, 2023, no cybersecurity incidents have materially affected the company's business strategy, results of operations, or financial condition[681](index=681&type=chunk) [Item 2. Properties](index=127&type=section&id=Item%202.%20Properties) The company's headquarters are located in leased office space in Palo Alto, California, which it believes is suitable for its current business needs - The company's principal executive offices are located at 3000 El Camino Real, Bldg. 4, Suite 200, Palo Alto, CA 94306[683](index=683&type=chunk) [Item 3. Legal Proceedings](index=127&type=section&id=Item%203.%20Legal%20Proceedings) The company is involved in various legal proceedings, with details incorporated from financial statement Note 9, and management does not anticipate a material adverse effect - The company is involved in litigation that arises in the ordinary course of business; specific details are incorporated by reference from Note 9 – Commitments and Contingencies in the financial statements[685](index=685&type=chunk) [Item 4. Mine Safety Disclosures](index=127&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable PART II [Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=128&type=section&id=Item%205.%20Market%20for%20the%20Registrant's%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock and warrants trade on Nasdaq, with **852,758 shares** outstanding as of March 19, 2024, and no cash dividends are anticipated in the foreseeable future - The company's common stock and warrants trade on the Nasdaq Capital Market under symbols "ATNF" and "ATNFW"[689](index=689&type=chunk) - As of March 19, 2024, there were **852,758 shares** of common stock outstanding held by **71 holders of record**[690](index=690&type=chunk) - The company has never paid cash dividends and does not plan to in the foreseeable future[691](index=691&type=chunk) [Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=130&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The company reported a net loss of **$19.9 million** in 2023, a significant reduction from **$38.7 million** in 2022 due to impairment changes, but faces critical liquidity issues with a **$1.4 million** working capital deficit and substantial doubt about its going concern ability [Results of Operations](index=135&type=section&id=Results%20of%20Operations) Consolidated Results of Operations (Years Ended Dec 31) | Metric | 2023 ($) | 2022 ($) | Change (%) | | :--- | :--- | :--- | :--- | | Research and Development | 2,303,751 | 2,191,834 | 5% | | General and Administrative | 10,646,417 | 15,459,788 | (31%) | | **Total Operating Expenses** | **13,477,500** | **17,897,965** | **(25%)** | | Loss on Goodwill Impairment | 0 | (33,547,278) | N/A | | Loss on IP R&D Assets Impairment | (9,063,000) | (3,342,084) | 171% | | Change in Fair Value of Derivative Liabilities | 75,323 | 15,144,986 | (99.5%) | | **Net Loss** | **(19,935,112)** | **(38,726,259)** | **(48.5%)** | - The decrease in General and Administrative expenses in 2023 was primarily due to reductions in legal expenses (~**$2.8 million**), insurance (~**$0.8 million**), accrued bonuses (~**$0.7 million**), and stock-based compensation (~**$0.5 million**)[729](index=729&type=chunk) - The significant decrease in net loss for 2023 compared to 2022 is largely attributable to a **$33.5 million** goodwill impairment charge in 2022 that did not recur, partially offset by a **$9.1 million** IP R&D asset impairment in 2023 and a smaller gain from the change in fair value of derivative liabilities[731](index=731&type=chunk) [Liquidity and Capital Resources](index=136&type=section&id=Liquidity%20and%20Capital%20Resources) - The company's cash balance is only expected to be sufficient to fund planned business operations through approximately **May 2024**, raising substantial doubt about its ability to continue as a going concern[699](index=699&type=chunk)[739](index=739&type=chunk) Financial Position Summary (as of Dec 31) | Metric | 2023 ($) | 2022 ($) | | :--- | :--- | :--- | | Cash | 1,975,799 | 6,970,110 | | Working Capital (Deficit) | (1,422,710) | 3,270,608 | Cash Flow Summary (Years Ended Dec 31) | Metric | 2023 ($) | 2022 ($) | | :--- | :--- | :--- | | Net Cash Used in Operating Activities | (10,922,223) | (12,127,585) | | Net Cash Provided by Financing Activities | 5,907,887 | 10,873,606 | - Cash from financing activities in 2023 was primarily from the April and August offerings, which provided combined gross proceeds of approximately **$6.0 million**, and an additional **$0.8 million** from a repricing of the August offering[735](index=735&type=chunk)[744](index=744&type=chunk)[745](index=745&type=chunk) [Critical Accounting Estimates](index=138&type=section&id=Critical%20Accounting%20Estimates) - A critical accounting estimate involves the annual impairment assessment of In-Process Research and Development (IP R&D) assets[748](index=748&type=chunk)[749](index=749&type=chunk) - In 2022, the company recorded an IP R&D impairment loss of **$3.3 million**; in 2023, due to commercialization delays and other factors, the company recorded a full impairment loss of the remaining **$9.1 million**, reducing the asset's carrying value to zero[750](index=750&type=chunk)[752](index=752&type=chunk) [Item 7A. Quantitative and Qualitative Disclosures About Market Risk](index=140&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, the primary market risk is interest rate sensitivity on cash and cash equivalents, though a 100 basis point change would not materially affect their fair value - The company's primary market risk is interest rate sensitivity; as of December 31, 2023, it held **$1,975,799** in cash and cash equivalents[754](index=754&type=chunk) [Item 8. Financial Statements and Supplemental Data](index=140&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplemental%20Data) The required financial statements and supplemental data are included in the report starting on page F-1 - The company's consolidated financial statements are included in the report, indexed on page F-1[755](index=755&type=chunk) [Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=140&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes in or disagreements with its accountants on accounting and financial disclosure - None [Item 9A. Controls and Procedures](index=141&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls and internal control over financial reporting were effective as of December 31, 2023, having remediated a material weakness related to fair value calculation review - Management concluded that disclosure controls and procedures were effective as of December 31, 2023[757](index=757&type=chunk) - A material weakness identified in 2022 related to imprecise review of fair value calculations for warrants and IP R&D assets has been remediated as of December 31, 2023[762](index=762&type=chunk)[763](index=763&type=chunk) - Management concluded that the company's internal control over financial reporting was effective as of December 31, 2023[760](index=760&type=chunk) [Item 9B. Other Information](index=142&type=section&id=Item%209B.%20Other%20Information) During the fourth quarter of 2023, none of the company's directors or officers adopted or terminated any Rule 10b5-1 trading plans or non-Rule 10b5-1 trading arrangements - No directors or officers adopted or terminated Rule 10b5-1 trading plans during the quarter ended December 31, 2023[766](index=766&type=chunk) PART III [Items 10-14](index=143&type=section&id=Items%2010-14) Information for Items 10 through 14, covering governance, compensation, and ownership, is incorporated by reference from the forthcoming 2024 Proxy Statement - Information for Items 10, 11, 12, 13, and 14 is incorporated by reference from the forthcoming 2024 Proxy Statement[768](index=768&type=chunk) PART IV [Item 15. Exhibits, Financial Statements and Schedules](index=144&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statements%20and%20Schedules) This section provides an index of the consolidated financial statements, which begin on page F-1, and a list of all exhibits filed with or incorporated by reference into the Annual Report on Form 10-K - This item contains the index to the consolidated financial statements and the exhibit index for the report[774](index=774&type=chunk)[776](index=776&type=chunk) [Item 16. Form 10–K Summary](index=151&type=section&id=Item%2016.%20Form%2010%E2%80%93K%20Summary) The company reports that there is no Form 10-K summary - None Consolidated Financial Statements [Financial Statements Overview](index=155&type=section&id=Financial%20Statements%20Overview) For FY2023, the company reported a **$19.9 million** net loss, ending with **$2.0 million** cash and a **$1.4 million** working capital deficit, with auditors expressing substantial doubt about its going concern ability Key Financial Data (as of and for the year ended Dec 31, 2023) | Metric | Amount ($) | | :--- | :--- | | **Balance Sheet:** | | | Cash | 1,975,799 | | Total Assets | 5,259,476 | | Total Liabilities | 5,387,209 | | Total Stockholders' (Deficit) | (127,733) | | **Statement of Operations:** | | | Total Operating Expenses | 13,477,500 | | Net Loss | (19,935,112) | | **Cash Flow:** | | | Net Cash Used in Operating Activities | (10,922,223) | - The independent auditor's report contains an explanatory paragraph highlighting substantial doubt about the company's ability to continue as a going concern due to significant working capital deficiency and recurring losses[795](index=795&type=chunk) [Notes to Consolidated Financial Statements](index=161&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) Notes to financial statements detail significant accounting policies, including going concern doubt, asset impairments, derivative liabilities, debt, equity, ongoing litigation, and subsequent events like the 2024 reverse stock split and Nasdaq compliance efforts - **Going Concern (Note 2):** The company has incurred significant losses, has a working capital deficit, and expects to require additional capital to fund operations; these conditions raise substantial doubt about its ability to continue as a going concern[831](index=831&type=chunk)[832](index=832&type=chunk) - **Impairment of Assets (Note 5):** The company recorded a goodwill impairment loss of **$33.5 million** in 2022; it also recorded IP R&D asset impairment losses of **$3.3 million** in 2022 and a further **$9.1 million** in 2023, writing the asset's value down to zero[868](index=868&type=chunk)[873](index=873&type=chunk)[875](index=875&type=chunk) - **Litigation (Note 9):** The company is involved in multiple legal actions, including a suit against its former CEO Dr. Marlene Krauss for over **$11 million**, a suit by Dr. Krauss for advancement of legal fees, and a dispute with Tyche Capital LLC over a funding guarantee[914](index=914&type=chunk)[919](index=919&type=chunk)[922](index=922&type=chunk) - **Stockholders' Equity & Nasdaq Compliance (Note 10):** The company details its non-compliance with Nasdaq's minimum bid price, shareholder approval, and minimum stockholders' equity rules; it also describes the reverse stock splits in 2022 and 2024 aimed at addressing these issues[992](index=992&type=chunk)[1049](index=1049&type=chunk)[1052](index=1052&type=chunk) - **Subsequent Events (Note 13):** Key events after year-end include amendments reducing executive salaries, a **1-for-19 reverse stock split** effective Feb. 28, 2024, regaining Nasdaq bid price compliance on March 12, 2024, and the appointment of new independent board members[1077](index=1077&type=chunk)[1086](index=1086&type=chunk)[1090](index=1090&type=chunk)
180 Life Sciences Regains Full Compliance with Nasdaq Minimum Bid Price Requirement
Newsfilter· 2024-03-14 12:30
PALO ALTO, Calif., March 14, 2024 (GLOBE NEWSWIRE) -- 180 Life Sciences Corp. (NASDAQ:ATNF) ("180 Life Sciences" or the "Company"), today announced that the Company received a letter on March 13, 2024 from The Nasdaq Stock Market LLC ("Nasdaq") indicating that the Company has regained full compliance with the minimum bid price for continued listing on the Nasdaq pursuant to Nasdaq Listing Rule 5550(a)(2) ("Minimum Bid Price Requirement"). As indicated in the letter, Nasdaq determined that for 10 consecutive ...
180 Life Sciences Corp. Announces 1-For 19 Reverse Stock Split as Part of Nasdaq Compliance Plan
Newsfilter· 2024-02-26 12:00
PALO ALTO, Calif., Feb. 26, 2024 (GLOBE NEWSWIRE) -- 180 Life Sciences Corp. (NASDAQ:ATNF) ("180 Life Sciences" or the "Company"), today announced that it will conduct a reverse stock split of its outstanding shares of common stock at a ratio of 1-for-19 (the "Reverse Stock Split"). The Reverse Stock Split is expected to become effective on February 28, 2024 at 12:01 p.m. Eastern Time (the "Effective Time"), with shares expected to begin trading on the Nasdaq Capital Market, on a split-adjusted, at market o ...
180 Life Sciences (ATNF) - 2023 Q3 - Quarterly Report
2023-11-08 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D. C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-38105 180 LIFE SCIENCES CORP (Exact name of registrant as specified in its charter) | --- | --- | |-------------------------- ...
180 Life Sciences (ATNF) - 2023 Q2 - Quarterly Report
2023-08-14 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D. C. 20549 Delaware 90-1890354 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, par value $0.0001 per share ATNF The NASDAQ Stock Market LLC (The NASDAQ Capital Market) Warrants to purchase Common Stock ATNFW The NASDAQ Stock Market LLC (The NASDAQ Capital Market) FORM 10-Q (Mark One) ☒ QUARTERLY REPORT ...
180 Life Sciences (ATNF) - 2023 Q1 - Quarterly Report
2023-05-14 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D. C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-38105 NCES 180 LIFE SCIENCES CORP (Exact name of registrant as specified in its charter) | --- | --- | |------------------------- ...
180 Life Sciences (ATNF) - 2022 Q4 - Annual Report
2023-03-30 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from: __________ to __________ Commission File Number: 001-38105 180 LIFE SCIENCES CORP. (Exact name of registrant as specified in its charter) | --- | --- | |--------- ...