Clinical Trials and Product Development - BiondVax Pharmaceuticals has executed eight clinical trials, including a phase 3 trial with 12,400 participants for its previous lead drug candidate, M-001[68] - The company has developed a pipeline of diversified products based on its innovative nanosized antibody (NanoAb) platform, which is expected to provide competitive advantages in treatment efficacy and delivery methods[71] - BiondVax signed a definitive exclusive License Agreement with the Max Planck Society and University Medical Center Göttingen for the development of NanoAbs for COVID-19, which includes upfront payments and royalties based on sales[69] - The company anticipates that its NanoAbs can be developed and brought to clinical trials at a lower cost and faster timeline compared to traditional monoclonal antibodies[73] - BiondVax's NanoAbs demonstrate binding affinity and neutralization at doses 100 to 1000 times lower than other antibodies, potentially leading to faster medical efficacy[72] - The company aims to leverage its unique NanoAb attributes to address large and underserved medical needs in various therapeutic areas, including psoriasis and asthma[71] Manufacturing and Financial Support - BiondVax's GMP biologics manufacturing facility in Jerusalem is capable of producing clinical-grade NanoAbs, allowing for direct control over production and reduced reliance on third-party manufacturers[76] - The company has borrowed €24 million under a finance contract with the European Investment Bank to support the development of its previous drug candidate and manufacturing facility[77] - The company has received $5.8 million in IIA grants and €24 million ($25.6 million) in EIB loans since its inception[87] Financial Performance and Projections - For the three months ended March 31, 2023, the net loss was $3.5 million, compared to a net loss of $2.47 million for the same period in 2022, reflecting an increase in operating expenses[89] - Research and development expenses for the three months ended March 31, 2023, amounted to $2 million, up from $1.2 million in the same period in 2022, primarily due to the launch of NanoAb development[80] - As of March 31, 2023, the company had cash and cash equivalents of $10.9 million, a decrease from $15.5 million as of March 31, 2022[90] - The company raised gross proceeds of approximately $8 million from a public follow-on offering completed in December 2022[84] - The company expects to incur additional losses due to ongoing research and development activities and may need to secure additional funding to support these initiatives[79] - General and administrative expenses for the three months ended March 31, 2023, were $1.2 million, down from $1.4 million in the same period in 2022[88] - The company has an accumulated deficit of $119.3 million as of March 31, 2023[93] - The company plans to continue funding operations through public and private equity offerings, grants, and loans, but there is no assurance that additional funding will be available on acceptable terms[86] - The company anticipates that a significant portion of future research and development expenses will be directed towards clinical development projects, which are inherently unpredictable[81] Strategic Partnerships and Leadership - The company is actively engaged in identifying and evaluating partnership opportunities within the pharmaceutical industry to enhance its market presence[73] - BiondVax's leadership team has extensive experience in the biotech and pharmaceutical sectors, which is expected to drive the company's strategic initiatives[76]
Scinai Immunotherapeutics .(SCNI) - 2023 Q1 - Quarterly Report