Tiziana Life Sciences (TLSA) - 2023 Q4 - Annual Report

PART I Item 3: Key Information Selected consolidated financial data for the past five years highlights net losses, decreased assets, and significant operational and financial risks Financial Highlights (in thousands) | Financial Metric | 2023 (Thousands USD) | 2022 (Thousands USD) | 2021 (Thousands USD) | | :--- | :--- | :--- | :--- | | Operations Data | | | | | Research and development | $(8,113) | $(12,955) | $(13,208) | | General and administrative | $(9,871) | $(1,631) | $(13,311) | | Net loss attributable to ordinary shareholders | $(17,691) | $(15,397) | $(23,417) | | Basic and diluted net loss per ordinary share | $(0.15) | $(0.15) | $(0.24) | | Balance Sheet Data (End of Period) | | | | | Cash and cash equivalents | $1,183 | $18,122 | $42,186 | | Total assets | $12,184 | $26,477 | $48,826 | | Total shareholders' equity | $5,534 | $19,571 | $41,280 | Risk Factors The company faces substantial risks including clinical trial failures, funding needs, reliance on third parties, commercialization challenges, and regulatory complexities - The company has incurred significant net losses since its inception in 2013, with a net loss of $17.8 million in 2023 and an accumulated loss of $134 million as of December 31, 2023, anticipating continued losses for the foreseeable future[56] - Substantial additional funding is required to complete product development, as failure to obtain this capital may force delays, limitations, or termination of development and commercialization efforts[61][65] - The company relies heavily on licenses from Nerviano, Lonza, and Novimmune for its product candidates, and failure to comply with license obligations could result in the loss of essential rights[105][111] - As a foreign private issuer (FPI), the company is exempt from certain SEC disclosure and corporate governance rules applicable to U.S. companies, potentially resulting in less publicly available information and different shareholder protections[238][240] Item 4: Information on the Company Tiziana Life Sciences is a clinical-stage biotechnology company developing therapies for neurodegenerative and lung diseases, with a focus on its product pipeline History and Development of the Company The company reorganized its corporate structure in October 2021, establishing Tiziana Life Sciences Ltd as the ultimate Bermuda-incorporated parent - The company reorganized its corporate structure in October 2021, making Tiziana Life Sciences Ltd, a Bermuda-incorporated company, the ultimate parent of the Tiziana Group[268] Business Overview Tiziana focuses on developing intranasally-administered Foralumab for neurodegenerative diseases, utilizing a lean R&D model and strong IP - The company's near-term strategic focus is on the clinical development of intranasally-administered Foralumab for treating neurodegenerative diseases, particularly Secondary Progressive Multiple Sclerosis (SPMS), with other development programs temporarily paused[308][295] Product Pipeline Overview | Product Candidate | Target Indication | Development Stage | | :--- | :--- | :--- | | Foralumab (TZLS-401) | Secondary Progressive MS (SPMS) | Phase 2a initiated Q3 2023 | | | Alzheimer's Disease | IND cleared Aug 2023 | | | Crohn's Disease (Oral) | Phase 1b withdrawn to focus on SPMS | | Milciclib (TZLS-201) | KRAS-mutated NSCLC | Program temporarily paused | | TZLS-501 (Anti-IL6R) | Systemic Sclerosis (SSc-ILD) | Program temporarily paused | - In an Expanded Access Program, 5 out of 6 non-active SPMS patients treated with intranasal foralumab showed a reduction in microglial activation as measured by PET scans, with the first patient showing a 38% reduction at 6 months[360][285][286] Item 5: Operating and Financial Review and Prospects Detailed analysis of financial performance reveals a net loss, decreased R&D expenses, increased G&A, and a going concern uncertainty - The independent auditor's report raises substantial doubt about the Group's ability to continue as a going concern, as management's forecast indicates current cash reserves will be depleted by July 2024 without new financing[826][856][857] Operating Expenses and Loss for the Year (in thousands) | Metric (Thousands USD) | 2023 (Thousands USD) | 2022 (Thousands USD) | Change (Thousands USD) | | :--- | :--- | :--- | :--- | | Research and Development | $(8,113) | $(12,955) | $4,842 | | Operating expenses | $(9,871) | $(1,638) | $(8,233) | | Loss for the year | $(17,691) | $(15,404) | $(2,287) | - R&D expenses decreased by $4.8 million in 2023 compared to 2022, reflecting focused expenditure on the foralumab Phase 2 trial for SPMS and the absence of manufacturing costs for TZLS-501[585] - General and administrative expenses increased by $8.2 million in 2023, driven by higher option-related expenses, increased PR/IR costs, and a $4.7 million net loss from unfavorable foreign exchange movements[586] Cash Flow Summary (in thousands) | Cash Flow (Thousands USD) | 2023 (Thousands USD) | 2022 (Thousands USD) | | :--- | :--- | :--- | | Net cash used in operating activities | $(15,698) | $(19,615) | | Net cash used in investing activities | $(1,253) | $(3,996) | | Net cash provided by (used in) financing activities | $40 | $(55) | | Net decrease in cash | $(16,911) | $(23,666) | Item 6: Directors, Senior Management and Employees This section details the company's leadership, compensation, board practices, and employee count Director Compensation (2023) | Name | Position | 2023 Total Compensation (Thousands USD) | | :--- | :--- | :--- | | Gabriele Cerrone | Executive Chairman | 817 | | Willy Simon | Non-Executive Director | 89 | | John Brancaccio | Non-Executive Director | 89 | - Executive Chairman Gabriele Cerrone has a long-term realization bonus agreement entitling him to 6.5% of the enterprise value if the company is sold for $1 billion or more during his directorship or within 10 years thereafter[635] - As of December 31, 2023, the company had 9 full-time employees, with 3 in R&D and 6 in management, administration, and finance[713] Item 7: Major Shareholders and Related Party Transactions Discloses ownership structure, with Executive Chairman Gabriele Cerrone holding significant influence, and outlines related party dealings - As of March 31, 2024, Executive Chairman Gabriele Cerrone beneficially owned approximately 38.71% of the company's ordinary shares, indicating significant influence over shareholder matters[718][254] - The company has engaged in transactions with related parties, including a shared services agreement with OKYO Pharma Ltd and a loan facility later converted into an equity investment in OKYO Pharma Ltd[978][979] Item 10: Additional Information Supplementary details cover material contracts, Bermuda exchange controls, and U.S. federal and Bermuda tax considerations for shareholders - The company believes it was a Passive Foreign Investment Company (PFIC) for the 2023 tax year, which could have adverse U.S. federal income tax consequences for U.S. shareholders, and the company does not intend to provide the information necessary for a QEF election[259][260] - As a Bermuda exempted company listed on Nasdaq, Tiziana has general permission from the Bermuda Monetary Authority for the issuance and transfer of its securities to non-residents for exchange control purposes[736] Item 11: Quantitative and Qualitative Disclosures About Market Risk The company's primary market risks are limited to interest rate and foreign currency exchange fluctuations, without hedging activities - The company's main market risks are interest rate and foreign currency exchange fluctuations, primarily between the U.S. dollar and Pound Sterling[775][965] - The company does not currently use currency hedging instruments to manage its foreign currency exposure[779] PART II Item 15: Controls and Procedures Management concluded disclosure controls were ineffective due to a material weakness in internal control over financial reporting related to an employee handbook - Management concluded that as of December 31, 2023, the company's disclosure controls and procedures were not effective[787] - A material weakness was identified in the internal control over financial reporting related to the failure to timely develop and communicate an employee handbook[793][251] - Management's remediation plan involves developing and maintaining an Employee Handbook for employees to reference[794] Item 16K: Cybersecurity The Board of Directors oversees cybersecurity risks, supported by senior leadership and third-party security evaluations - The full Board of Directors retains oversight of cybersecurity, and senior leadership, along with a cybersecurity consultant, regularly briefs the Board on the company's security posture[810] - The company utilizes an incident response playbook and engages third-party services for security evaluations, such as penetration testing and independent audits[810][811] PART III Item 18: Financial Statements Audited consolidated financial statements for 2021-2023 are presented, with the auditor highlighting a material uncertainty regarding going concern - The financial statements have been prepared assuming the company will continue as a going concern, but the auditor's report notes that the company's pre-revenue status and ongoing R&D expenditure raise substantial doubt about this ability, with cash forecast to be utilized by July 2024 without additional financing[826] Consolidated Balance Sheet Highlights (in thousands) | (Thousands USD) | Dec 31, 2023 (Thousands USD) | Dec 31, 2022 (Thousands USD) | | :--- | :--- | :--- | | Total Assets | $12,184 | $26,477 | | Total Current Assets | $7,337 | $24,282 | | Total Non-Current Assets | $4,847 | $2,195 | | Total Liabilities | $6,648 | $6,906 | | Total Current Liabilities | $6,539 | $6,663 | | Total Shareholders' Equity | $5,536 | $19,571 |