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Scinai Immunotherapeutics .(SCNI) - 2022 Q4 - Annual Report

Financial Performance - For the year ended December 31, 2022, the net loss was $5.8 million, a decrease from the net loss of $8.2 million for the year ended December 31, 2021, reflecting improved financial performance [313]. - The accumulated deficit amounted to $115.8 million as of December 31, 2022, indicating ongoing financial challenges [318]. - The company expects to continue incurring operating losses and may need to raise additional funds to support its research and development activities [303]. Research and Development - Research and development expenses increased to $5.7 million for the year ended December 31, 2022, compared to $3.2 million for the year ended December 31, 2021, primarily due to increased salaries and expenses related to the COVID-19 NanoAb project [304]. - The company signed a five-year Research Collaboration Agreement with MPG and UMG for the discovery and development of NanoAbs for various diseases, which are expected to address large and growing markets [300]. - The company anticipates that a significant portion of future research and development expenses will be related to its clinical development projects, which are inherently unpredictable [305]. Cash and Funding - As of December 31, 2022, the company had cash and cash equivalents of $14 million, down from $17.3 million as of December 31, 2021 [314]. - The company raised gross proceeds of approximately $8 million from a public follow-on offering completed in December 2022 [308]. - The Company closed an underwritten offering selling 1,600,000 units, receiving a net sum of $7.3 million after issuance expenses [321]. - Each unit was sold at a combined purchase price of $5.00, with pre-funded units priced at $4.999 [321]. - The company has received $5.8 million in IIA grants and €24 million ($25.6 million) in EIB loans since its inception, which have supported its operations [311]. Clinical Trials - The company has executed eight clinical trials, including a phase 3 trial with 12,400 participants for its previous lead drug candidate, M-001, which is no longer under development [297]. Asset Valuation - No impairment indicators for long-lived assets were identified during the years ended December 31, 2022 and 2021 [324]. - The fair value of financial instruments is measured based on a three-tiered hierarchy prioritizing inputs used in valuation methodologies [325]. - The Company is not required to provide market risk disclosures as it qualifies as a smaller reporting company [326].