Tivic Health Systems, Inc. Q1 FY2025 earnings call

• Tivic has transformed from a single product company to a diversified immunotherapeutics company. In February, it secured exclusive worldwide rights to the late-stage immunomodulatory drug candidate Entolimod and options on Entolasta. - Michael Handley joined as Chief Operating Officer and President of Tivic Biopharma, bringing experience in launching 17 new drugs. - Entolimod's Phase 3 trials are complete under the FDA's animal pathway rules, and a manufacturing validation agreement for GMP production and scale up was announced. - The company is advancing Entolimod along the commercialization pathway, with the licensing agreement being a key focus, and the immunomodulatory effects of Entolimod and Entolasta complementing the non-invasive vagus nerve stimulation work. - A $8.4 million tranche funding agreement was signed to infuse capital at critical points while managing dilution.

Revenue for the first quarter ended March 31, 2025, was $70,000, a decrease from $334,000 in the prior year quarter, primarily due to an 81% reduction in unit sales from decreased marketing spend. Cost of sales decreased to $20,000 from $167,000 in the prior year quarter, resulting in gross margins increasing from 50% to 72%. Operating expenses remained flat at $1.6 million for the first quarter of 2025 compared to the same period in 2024. Net loss for the quarter remained flat at $1.5 million. Cash and cash equivalents totaled $669,000 at March 31, 2025, compared with $2 million at December 31, 2024. Working capital was $520,000, and there was no debt at the end of the first quarter. Subsequent to the quarter, net proceeds of $1.7 million were raised via an Equity Distribution Agreement, and a $25 million equity line of credit was secured with the first drawdown expected in the second quarter. An $8.4 million strategic financing was also entered into in May.

• Funds from the equity line of credit and strategic financing will support advancing clinical and pre-commercial activities. - GMP manufacturing validation for Entolimod is a key inflection point transitioning from clinical to commercialization. - VNS program data expected to be complete and readouts provided over the summer, with a comprehensive report expected then. - Annual General Meeting upcoming with voting on measures related to the strategic transformation.

Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those indicated. Risks include uncertainties in clinical trial outcomes, regulatory approvals, market adoption of new products, and potential impacts from economic conditions.

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