Tivic Health Systems, Inc. Q4 FY2024 earnings call

• Acquired worldwide exclusive rights to a phase three immunomodulatory drug candidate Intellimod from Staterra Biopharma, with over $140 million previously invested in the candidate. Intellimod is a TLR5 agonist for acute radiation syndrome and has potential for other immune-related indications.
• Developed a noninvasive vagus nerve stimulation device, with positive signals showing potential to regulate immune and autonomic systems.
• Hired Michael K. Hanley as COO to lead biopharma activity, including advancing Intellimod and the second licensed compound Entelasta through clinical and regulatory trials.
• Completed phase three studies for Intellimod, moving to manufacturing validation for potential FDA approval.
• Optimizing noninvasive vagus nerve stimulation with the Feinstein Institute, where personalized stimulation showed a 400% increase in effects.
• Secured an expanded IP portfolio, including patents for personalized vagus nerve stimulation.
• Closed a $25 million equity line of credit for funding development stages.
• Conducted a seventeen-for-one reverse stock split to meet NASDAQ listing requirements.

Revenue net of returns for 2024 was $0.8 million, down from $1.2 million in 2023, primarily due to a 41% decrease in unit sales. Cost of sales in 2024 was $0.8 million, a 12% decrease from 2023, also linked to unit sales decline. Gross profit in 2024 was $2,000, compared to $287,000 in 2023. Total operating expenses in 2024 were $5.7 million, down from $8.5 million in 2023. Net loss for 2024 was $5.7 million, lower than $8.2 million in 2023. Cash and cash equivalents at December 31, 2024, were $2 million, down from $3.4 million in 2023. Working capital was $2.4 million at year-end 2024. The company had no debt as of year-end 2024 or 2023.

• Prioritize advancing Intellimod towards revenue generation.
• Expect to start disease-specific trials for the noninvasive vagus nerve stimulation device later in 2025.
• Anticipate FDA approval for Intellimod within approximately two years, with potential for emergency use in other markets.
• Plan to advance Entelasta through clinical and regulatory trials.

• Dependence on successful regulatory approvals for Intellimod and the vagus nerve stimulation device.
• Uncertainty in market reception and reimbursement for new immunotherapy and neuromodulation treatments. -- Competition in the biopharmaceutical and neuromodulation sectors. -- Need for continued capital infusions to support drug and device development until commercialization.

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