Financial Data and Key Metrics Changes - R&D expenses for the first six months of 2024 were approximately $2.79 million, down from $3.45 million in the same period of 2023, primarily due to reduced salaries and subcontractor usage [6] - Marketing and G&A expenses decreased to $1 million from $2.3 million year-over-year, attributed to lower salaries, share-based compensation, and professional services [6] - Financial expenses also decreased from $1.5 million in the first half of 2023 to $0.53 million in 2024, mainly due to prior year adjustments related to warrants and loan revaluation [6] - The net loss for the first six months of 2024 was $4.48 million, compared to $7.28 million in the same period of 2023, reflecting reduced operating expenses across all business units [6] - Cash available as of June 30, 2024, was $3.21 million, down from $7.63 million a year earlier [7] - Shareholder equity at the end of Q2 2024 was negative $7.28 million, but a debt-to-equity deal expected to close soon should increase it by approximately $19 million, potentially resulting in positive equity [7][8] Business Line Data and Key Metrics Changes - The company reported its first CDMO revenues in Q2 2024 and received a grant from the Israel Innovation Authority to support CDMO ramp-up, contributing to reduced cash burn [7] - The CDMO business unit aims for sales of $1.25 million in 2024, with a current pipeline of work orders valued at $600,000 from five clients [21] Market Data and Key Metrics Changes - The company is actively pursuing marketing activities, including participation in major pharmaceutical conferences to enhance brand awareness and attract potential partners [21] - The CDMO unit is positioned to meet the growing demand for boutique services from early-stage biotech companies, which is expected to increase revenues materially in the coming years [21] Company Strategy and Development Direction - The strategic guidelines for 2024 include fast-tracking IL-17 development, ramping up the CDMO business unit, and careful spending to sustain cash flow [5] - The company aims to partner with other pharmaceutical companies to hedge R&D risks and ensure sufficient capital for ongoing projects [5] - The focus is on developing a pipeline of nanoAb-based drugs targeting diseases with unmet needs, leveraging collaborations with prestigious institutions like the Max Planck Society [22] Management's Comments on Operating Environment and Future Outlook - Management believes Scinai is undervalued and highlights the potential for growth following the resolution of significant liabilities on the balance sheet [23] - The company is optimistic about its regulatory strategy and the potential for its lead antibody candidate, with plans to commence human trials in 2025 [25][28] - The long-term vision includes engaging with larger pharmaceutical companies for partnerships and sublicensing to ensure reliable commercial launches [29] Other Important Information - The company has received positive regulatory feedback from the Paul Erlich Institute regarding its drug development program, which is expected to lead to a Phase 1/2a clinical trial in the second half of 2025 [11][12] - The EIB debt-to-equity restructuring is anticipated to close soon, which will significantly improve the company's financial position [9][27] Q&A Session Summary Question: What do you see as the long-term future and share price of Scinai? - Management believes Scinai is undervalued and invites comparisons with similar companies at a preclinical stage, emphasizing the depth of its product pipeline and the unique position of its CDMO business [23] Question: Can you elaborate on the clinical and commercial potential and timeline of your lead antibody candidate? - The company plans to conduct further animal studies to optimize dosing schedules before initiating human trials, with the goal of starting Phase 1/2a trials in the second half of 2025 [25] Question: What are some key regulatory considerations and strategies Scinai is employing? - The company is working with experienced regulatory advisors to develop a robust data package for regulatory agencies, aiming for a more efficient path to market [28] Question: What is your long-term vision for Scinai? - The strategy involves leveraging patented technology through partnerships with larger pharma companies while maintaining a focus on R&D and the CDMO business unit to generate cash flow and reduce risks [29]
Scinai Immunotherapeutics .(SCNI) - 2024 Q2 - Earnings Call Transcript