Biora Therapeutics (BIOR) Q3 2024 earnings summary

Executive summary

• Clinical-stage biotech focused on oral biotherapeutics, with NaviCap for GI-targeted and BioJet for systemic delivery; advanced development of smaller, higher-capacity BioJet device with animal testing planned in Q4 2024.

• Shifted partnering strategy to focus on licensing BioJet device, citing strong pharma interest.

• No significant product revenue; pipeline in early clinical and preclinical stages, with ongoing R&D investment.

• Underwent two reverse stock splits (1-for-25 in Jan 2023, 1-for-10 in Oct 2024) to maintain Nasdaq compliance.

• Substantial doubt exists about ability to continue as a going concern due to limited cash and high accumulated deficit.

Financial highlights

• Revenue for Q3 2024 was $32,000, up from $4,000 in Q3 2023; nine-month revenue was $892,000.

• Net loss for Q3 2024 was $18.4M, improved from $73.5M in Q3 2023; nine-month net loss was $16.1M, improved from $108.7M.

• Operating expenses for Q3 2024 were $16.3M, down from $23.3M in Q3 2023 and $16.1M in Q2 2024.

• Cash and equivalents at September 30, 2024 were $3.0M–$3.2M, with a working capital deficit and $967.1M accumulated deficit.

• Cash used in operations for the nine months ended September 30, 2024 was $32.2M.

Outlook and guidance

• Current cash is not expected to fund operations for 12 months; additional capital is required.

• Plans to raise capital through equity offerings, debt financings, or strategic transactions.

• R&D expenses expected to remain flat in 2024 as clinical trials continue.

• Plans to share additional canine study data and begin primate studies with BioJet device in Q4 2024.

• Operating cash burn reduced by 40% to under $2.5M per month going forward.