None
Strong Financial Performance:
-
reported
net income of
$2.9 million for Q1 2025, compared to a
net loss of
$3.2 million in the first quarter of the previous year.
- The improvement was driven by an increase in research and development revenue, due to the BARDA Project BioShield contract, and reduced general and administrative expenses.
FDA Submission and Regulatory Progress:
- The company is on track to meet its FDA De Novo classification submission by the end of Q2 2025, a key milestone for regulatory approval.
- Confidence in the submission process is bolstered by a 12-year relationship with BARDA and over 10 pre-sub meetings with the FDA, enhancing the likelihood of a successful outcome.
Funding and Cash Runway:
- Spectral AI raised approximately
$10.2 million in funding, including a debt financing agreement of up to
$15 million with Avenue Capital and an equity financing of
$2.7 million.
- This has resulted in over
$14 million in cash on hand, providing a substantial runway for growth initiatives and product commercialization.
Reduced General and Administrative Expenses:
- General and administrative expenses were reduced from
$5.1 million in Q1 2024 to
$4.1 million in Q1 2025.
- The decline is attributed to a focus on the BARDA Project BioShield contract and cost-cutting measures, which have improved operational efficiency.
MTEC Development and Milestones:
- Spectral AI has assembled two functional prototypes of the DeepView System handheld device, marking a key milestone in the
development contract.
- The development is on track, with plans to advance industrial design and environmental testing to ensure rugged performance for military operations.
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