Financial Performance - The company generated research and development revenue of $6,707,000 for the three months ended March 31, 2025, representing a 6.0% increase from $6,326,000 in the same period of 2024[115]. - Gross profit for the same period was $3,168,000, with a gross margin of 47.2%, compared to a gross profit of $2,945,000 and a gross margin of 46.6% in 2024[101]. - The company reported a net income of $2,897,000 for the three months ended March 31, 2025, a significant improvement from a net loss of $3,205,000 in the prior year[114]. - Operating loss for the three months ended March 31, 2025, was $896,000, a reduction from an operating loss of $2,143,000 in the same period of 2024[114]. - Adjusted EBITDA for the three months ended March 31, 2025, was $(694) thousand, improving from $(1,857) thousand in the comparable period in 2024[126]. - General and administrative expenses decreased by 20.1% to $4.1 million for the three months ended March 31, 2025, down from $5.1 million in 2024[119]. - Net cash used in operating activities decreased by approximately $1.2 million to $(1.5) million for the three months ended March 31, 2025[136]. - Net cash provided by financing activities increased to approximately $10.3 million for the three months ended March 31, 2025, compared to $8.0 million in 2024[137]. Contracts and Funding - The company has received a new contract with BARDA, providing up to $150 million in funding, including an initial award of approximately $54.9 million for clinical validation of the DeepView System[95]. - The total potential support from BARDA is nearly $272.9 million, including the new PBS BARDA Contract valued at $54.9 million[128]. - The company has received a $4.9 million grant from MTEC, intended to support military battlefield burn evaluation via a handheld DeepView System device[96]. Clinical Studies and Product Development - The company completed enrollment of a pivotal clinical study with 267 patients, including 42 pediatric patients, across 22 sites in the United States[93]. - The company anticipates two revenue streams from the DeepView System: a software as a medical device (SaMD) model and an imaging device component[97]. - The company has not generated any product revenue to date, relying on contract development and research services for revenue[94]. Shareholder and Financing Activities - The company began trading its shares on the Nasdaq under the symbols "MDAI" and "MDAIW" following the completion of a Business Combination on September 12, 2023[99]. - The company entered into a Loan and Security Agreement allowing it to borrow up to $15.0 million, with an initial drawdown of $8.5 million[129]. - Avenue Financing includes warrant coverage equal to 8.5% of the total funding commitment, with an exercise price of $1.66[140]. - Spectral IP received a $1.0 million investment from an affiliate of its largest stockholder for developing artificial intelligence intellectual property[141]. - The Spectral IP Note was amended to reduce the annual interest rate from 8% to 4% and extend the term through March 18, 2026[142]. - The holder of the Spectral IP Note converted it into 540,996 shares of Common Stock at a 5% discount to the closing price[142]. Cash Position and Risks - As of March 31, 2025, the company had approximately $14.1 million in cash and an accumulated deficit of approximately $45.3 million[127]. - The company maintains a significant amount of cash, with interest rates on current borrowings at Prime plus 5.25%[152]. - The company has not recognized any losses from credit risks on cash, indicating a low exposure to significant credit risk[154]. - Inflationary pressures may adversely affect the company's gross margin and cash flows if costs continue to rise significantly[156]. Company Classification - The company is classified as an emerging growth company, allowing it to delay the adoption of certain accounting standards[147]. - One customer, a U.S. government agency, represents the majority of the company's research and development revenue and accounts receivable[155]. - The company has no off-balance sheet arrangements during the periods presented[143].
Spectral AI(MDAI) - 2025 Q1 - Quarterly Report