Cellectar Biosciences(CLRB) - 2024 Q4 - Annual Report

Financial Position and Performance - As of December 31, 2024, the company's consolidated cash balance was approximately $23.3 million, which is expected to fund basic operations into the fourth quarter of 2025[193]. - The company has incurred significant losses and negative cash flows from operations, raising substantial doubt about its ability to continue as a going concern[379]. - The company reported a net loss of$44.58 million in 2024, compared to a net loss of $42.77 million in 2023, with a basic net loss per share of$1.22[394]. - The company's accumulated deficit increased to $(247.34) million in 2024 from$(202.76) million in 2023, indicating ongoing financial challenges despite capital raises[391]. - Cash used in operating activities for 2024 was approximately $47.58 million, an increase from$32.38 million in 2023[399]. - The company expects to continue incurring significant losses and using net cash until product candidates are approved and commercialized[403]. - The company has restated its previously issued financial statements for the years ended December 31, 2022, and 2023, exposing it to additional risks and uncertainties[317]. - The restatement has led to potential liabilities and reputational harm, as well as increased costs related to accounting and legal fees[318]. Capital and Funding - The company expects to require additional capital to continue operations and may have difficulty raising such capital, impacting its ability to execute its operating plan[194]. - Management plans to secure additional outside capital to fund operations, with available liquidity limited to approximately $14.9 million as of the issuance date[405]. - Proceeds from the exercise of warrants amounted to approximately$61.41 million in 2024, compared to $0.79 million in 2023[399]. - The company entered into a warrant exercise inducement transaction, resulting in gross proceeds of$19.4 million and net proceeds of $17.5 million from the exercise of 1,610 shares of Series E-4 preferred stock, convertible to 6,739,919 shares of common stock at a price of$2.52 per share[385]. Research and Development - The company is focused on the discovery, development, and commercialization of drugs for cancer treatment using its PDC platform, which can target nearly all tumor cells[212]. - The company may need to delay, scale back, or eliminate research and development programs if it cannot secure adequate financing when needed[199]. - The company has engaged AtomVie and SpectronRx as sources to supply drug products for ongoing research and clinical studies[202]. - The company has received orphan drug designation (ODD) in the U.S. for iopofosine, which is intended for the treatment of multiple myeloma and other conditions[252]. - The FDA has granted rare pediatric disease designation to iopofosine for treating neuroblastoma, rhabdomyosarcoma, Ewing's sarcoma, and osteosarcoma, but the company may not realize value from this designation[189]. - Clinical studies are lengthy and expensive, with uncertain outcomes, and earlier study results may not predict future results[238]. Regulatory and Compliance Risks - The company must comply with extensive regulations governing the testing, manufacturing, and marketing of its products, which can delay or limit product introduction[229]. - The company may face significant challenges in obtaining sufficient quantities of its products at reasonable prices, even if they are shown to be safe and effective[213]. - The company must demonstrate substantial clinical evidence for safety and efficacy to obtain FDA approval, which can take many years and require significant resources[217]. - The company may face litigation from third parties claiming infringement of intellectual property rights, which could result in substantial costs[258]. - Regulatory changes and increased litigation scrutiny could negatively impact the company's business and financial condition[247]. Market and Competitive Landscape - The market for the company's proposed products is rapidly changing and competitive, which could impair its ability to develop its business[191]. - The potential for widespread acceptance of alternative therapies may limit market acceptance of the company's products, even if they are commercialized[294]. - The commercial success of the company's products will depend significantly on reimbursement from third-party payors, with ongoing trends to reduce costs impacting revenue[304]. - Market acceptance of the company's products is uncertain, and failure to achieve this could delay revenue generation[270]. Internal Controls and Governance - The company is required to establish and maintain effective internal controls over financial reporting, with evolving and complex standards that may incur significant expenses[322]. - There are identified material weaknesses in the company's internal controls that have previously resulted in restatements of historical financial statements[322]. - The company has experienced high volatility in its stock price, which may be affected by the issuance of additional shares or convertible securities[327]. - The company has received a deficiency letter from Nasdaq due to the closing bid price of its common stock being below the minimum requirement of $1.00 per share for 30 consecutive business days[324]. Personnel and Intellectual Property - The company's success significantly relies on the continued services of key personnel, including the CEO, James V. Caruso, and the ability to attract and retain highly skilled personnel[266]. - The company faces risks related to the protection of trade secrets and proprietary information, which could adversely affect its competitive position[267]. - The patent positions for biotechnology products are often uncertain, and the company may not be able to adequately protect its intellectual property rights[260].