Funding and Contracts - The company has received approximately $280.2 million in funding awards from government contracts since 2013, with $272.9 million coming from BARDA[128]. - The company executed a multi-year Project BioShield agreement with BARDA in September 2023, valued at up to approximately $150.0 million, including an initial award of nearly $54.9 million[129]. - The PBS BARDA Contract, valued at up to $150.0 million, includes an initial award of nearly $54.9 million for the clinical validation and FDA clearance of the DeepView system[170]. - The company received a $4.0 million grant under the MTEC Agreement for developing a handheld version of the DeepView System, expected to be completed by April 2025[171]. Financial Performance - Research and development revenue for the three months ended March 31, 2024, was $6.3 million, an increase of $1.2 million from $5.1 million in the same period in 2023[138]. - Gross profit for the same period was $2.9 million, with a gross margin of 46.6%, up from 42.9% in 2023[138]. - The operating loss for the three months ended March 31, 2024, was $2.1 million, a decrease of $755,000 compared to a loss of $2.9 million in 2023[138]. - The net loss for the same period was $3.2 million, a reduction of $404,000 from a net loss of $3.6 million in 2023[138]. - Adjusted EBITDA for the three months ended March 31, 2024, was $(2.1) million, an improvement from $(2.6) million in 2023[165]. - Net cash used in operating activities decreased by approximately $1.1 million to $(2,680) thousand for the three months ended March 31, 2024, compared to $(3,755) thousand in the same period of 2023[175]. - Net cash provided by financing activities increased by approximately $8.2 million to $8,049 thousand for the three months ended March 31, 2024, compared to $(104) thousand in the same period of 2023[176]. Product Development and Commercialization - The company has not generated any product revenue to date, focusing on research and development for the DeepView System[128]. - The DeepView System is expected to begin commercialization in the UK in the second half of 2024 following the receipt of the UKCA mark[125]. - The company anticipates two revenue streams from the DeepView System: a software as a medical device model and an imaging device component[131]. Corporate Structure and Governance - The business combination completed in September 2023 resulted in the company being listed on the Nasdaq under the symbols "MDAI" and "MDAIW"[133]. - The Company formed a new subsidiary, Spectral IP, and received a $1.0 million investment for the development of its artificial intelligence intellectual property portfolio[180]. Capital and Financing - As of March 31, 2024, the company had approximately $10.2 million in cash and notes payable of $5.8 million, with no long-term debt[166]. - The company entered into a Common Stock Purchase Agreement with B. Riley to sell up to $10.0 million in newly issued shares and a Standby Equity Purchase Agreement with Yorkville to sell up to $30.0 million in shares[167][168]. - The Company entered into a SEPA allowing the sale of up to $30.0 million of its shares, with an initial Pre-Paid Advance of $5.0 million at a fixed conversion price of $3.16[178]. - The Insurance Note, entered into in September 2023, has an interest rate of 8.6% per annum, with a remaining balance of $0.2 million as of March 31, 2024[177]. Risks and Challenges - The Company is exposed to credit risk, with one U.S. government agency representing the majority of its research and development revenue and accounts receivable[194]. - Inflation has contributed to increased costs in research and development and operating expenses, potentially affecting gross margins and cash flows[195]. - The Company has not recognized any losses from credit risks on cash, which is primarily held in U.S. financial institutions[193]. - The Company maintains a large amount of cash, with fixed interest rates on current borrowings, making it less sensitive to interest rate changes[191]. - The Company is classified as an emerging growth company, allowing it to delay the adoption of certain accounting standards[185].

As filed with the Securities and Exchange Commission on April 10, 2024 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 __________________________________ Spectral AI, Inc. (Exact name of registrant as specified in its charter) __________________________________ | Delaware | 8731 | 85-3987148 | | --- | --- | --- | | (State or other jurisdiction of | (Primary Standard Industrial | (I.R.S. Employer | ...

Technology and Product Development - The DeepView System has achieved 92% accuracy in identifying non-healing burn regions in adult participants, significantly outperforming burn specialists who reported 70-80% accuracy[33]. - The AI diagnostic accuracy for DFU has improved to 86% as of 2023, with a goal to predict a 50% reduction in wound size by week four[36]. - The DeepView System's current clinical accuracy for DFUs is 86%, while for burn wounds, it is 92%, compared to physician accuracy rates of 50% to 75%[52]. - The DeepView System's imaging technology captures a wide range of wavelengths, providing data that enhances the AI model's predictive capabilities[21]. - The company is developing 3-D wound measurement technology that will enable accurate distance, area, and volume measurements with sub-millimetric accuracy[42]. - The DeepView technology is the only AI-enabled wound imaging technology that provides a binary result of "healing vs. non-healing"[66]. - The company plans to submit a De Novo application to the FDA for market authorization of the burn application in early 2025[45]. Funding and Financials - The company has received approximately $279.6 million in funding from government contracts since 2013, with $272.9 million from BARDA, supporting technology development and clinical trials[25]. - A new contract with BARDA executed on September 27, 2023, provides up to $150 million in funding, including an initial award of approximately $54.9 million for clinical validation and FDA De Novo status application[25]. - The company incurred a net loss of $20.9 million for the year ended December 31, 2023, compared to a net loss of $2.9 million for the year ended December 31, 2022, with an accumulated deficit of $32.8 million as of December 31, 2023[87]. - The company may need additional funding to finance operations and product development, with no guarantee of raising capital on favorable terms[102]. - The company has the right to sell up to $10 million of common stock to B. Riley and up to $30 million to Yorkville under respective agreements[100]. Regulatory and Compliance Challenges - The company is subject to extensive regulations for medical devices, which can delay or prevent market authorization for the DeepView System[107]. - The company must comply with EU and UK regulations to market its medical devices, which may impose additional costs and delays[110][111]. - The FDA's evolving regulations may impose additional costs and lengthen review times for the DeepView System, affecting market authorization[118]. - The company is subject to various data protection laws, including HIPAA, which imposes significant obligations and potential penalties for non-compliance[151]. - The General Data Protection Regulation (GDPR) could impose fines of up to €20 million or 4% of annual global revenues for breaches, affecting the company's operations in the European Economic Area[156]. - Compliance with various healthcare laws, including the Anti-Kickback Statute and the False Claims Act, is crucial, as violations could result in substantial penalties and operational disruptions[142][143]. Market Strategy and Sales - The DeepView System is expected to begin commercial sales in the UK for burn indications in the second half of 2024, following UKCA authorization[26]. - The company intends to expand its sales efforts to outpatient wound centers and podiatric clinics in the US and Europe, targeting a mature sales model[27]. - The company plans to utilize a SaaS model and an imaging device component for revenue generation, with the SaaS component including a software licensing fee for maintenance and updates[69]. - The company plans to engage strategic partnerships and key opinion leaders to facilitate the adoption of its DeepView technology[72]. - The company has established relationships with leading U.S. hospitals to promote the DeepView System and increase awareness among key opinion leaders[170]. Operational Risks and Challenges - The company relies heavily on government funding, with the BARDA contract being its largest single source of revenue, and any loss of this funding could adversely impact operations[92]. - The company faces risks of significant delays in clinical trials, which could impair product launch and increase development costs[113]. - The company relies on third parties for clinical trials and regulatory submissions, and failures by these parties could adversely affect market authorization[116]. - The company is highly dependent on senior management and key personnel, and losing them could adversely impact business operations[202]. - The company faces challenges in accurately forecasting demand for its products, which could lead to inventory write-downs or supply chain disruptions[200]. Competition and Market Acceptance - The company faces competition from larger firms with established relationships and resources, which may hinder market penetration[182]. - Potential barriers to adoption include perceived liability risks, insufficient clinical evidence, and competition from established diagnostic products[173]. - The success of the DeepView System depends on clinician adoption, which is influenced by factors such as safety, performance, and cost-effectiveness[169]. - The company lacks experience in marketing and selling the DeepView System, which could hinder its ability to grow sales and brand awareness[172]. Cybersecurity and Data Protection - The company has taken steps to protect its information technology systems, but there is no assurance that these measures will prevent security breaches[213]. - The company may face significant costs and reputational damage from cyber-attacks or data breaches, which could adversely affect its financial condition[210]. - The company is exposed to risks from employee misconduct, which could lead to regulatory sanctions and reputational harm[161]. Workforce and Employment - The company employs 78 full-time employees as of December 31, 2023, and anticipates hiring in operations, sales, marketing, and government contracts in 2024[81]. - As of March 25, 2024, the company had 80 employees and anticipates a substantial increase in workforce to support growth plans[205]. - The company is implementing a long-term hiring plan to support its European strategy, which includes hiring in the UK and Europe[204].

As filed with the Securities and Exchange Commission on January 23, 2024 Registration No. 333-276406 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 _____________________________________ AMENDMENT NO. 1 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 _____________________________________ Spectral AI, Inc. (Exact name of registrant as specified in its charter) _____________________________________ (State or other jurisdiction of incorporation or organization) (Prim ...

As filed with the Securities and Exchange Commission on January 5, 2024 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 _____________________________________ Spectral AI, Inc. | | | (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) (Exact name of registrant as specified in its charter) ____ ...

As filed with the Securities and Exchange Commission on December 18, 2023 Registration No. 333-275218 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 AMENDMENT NO. 3 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Spectral AI, Inc. (Exact name of registrant as specified in its charter) | Delaware | 8731 | 85-3987148 | | --- | --- | --- | | (State or other jurisdiction of | (Primary Standard Industrial | (I.R.S. Employer | | incorporation or organization) | Classif ...

As filed with the Securities and Exchange Commission on December 7, 2023 Registration No. 333-275218 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 AMENDMENT NO. 2 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Spectral AI, Inc. (Exact name of registrant as specified in its charter) Delaware 8731 85-3987148 (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Numbe ...

As filed with the Securities and Exchange Commission on November 21, 2023 Registration No. 333-275218 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 AMENDMENT NO. 1 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ____________________________ Spectral AI, Inc. (Exact name of registrant as specified in its charter) ____________________________ | Delaware | 8731 | 85-3987148 | | --- | --- | --- | | (State or other jurisdiction of | (Primary Standard Industrial | (I. ...

Funding and Government Contracts - The company has received approximately $279.0 million in funding commitments from government contracts since 2013, primarily from BARDA, which accounts for $271.9 million[116]. - In September 2023, the company executed a multi-year Project BioShield contract with BARDA valued at up to approximately $149 million, including an initial award of nearly $55.0 million for clinical validation and FDA clearance[118]. - The company is highly dependent on U.S. governmental contracts, with revenue growth reliant on the continuation of these awards[136]. - The company received $4.0 million in grants under the MTEC Agreement in April 2023, contributing to its liquidity[162]. Financial Performance - The company reported research and development revenue of $3,440,000 for the three months ended September 30, 2023, compared to $7,038,000 for the same period in 2022[130]. - The gross margin for the three months ended September 30, 2023, was 42.8%, compared to 45.9% for the same period in 2022[130]. - The net loss for the three months ended September 30, 2023, was $10,629,000, compared to a net loss of $380,000 for the same period in 2022[130]. - Research and development revenue for Q3 2023 was $3,440,000, a decrease of 51.1% compared to $7,038,000 in Q3 2022[146]. - Gross profit for Q3 2023 was $1,472,000, down 54.4% from $3,227,000 in Q3 2022, with a gross margin of 42.8%[148]. - General and administrative expenses increased by 62.1% to $5,638,000 in Q3 2023, compared to $3,478,000 in Q3 2022, primarily due to increased staffing[150]. - Revenue from BARDA decreased by 55.7% to $3,055,000 in Q3 2023, down from $6,903,000 in Q3 2022[147]. - Total operating costs and expenses for Q3 2023 were $5,638,000, significantly higher than $3,478,000 in Q3 2022[145]. - Cost of revenue for Q3 2023 was $1,968,000, a decrease of 48.4% from $3,811,000 in Q3 2022[148]. - Net interest income for the three months ended September 30, 2023, was $2,000, compared to $42,000 for the same period in 2022, reflecting a decrease of approximately 95.2%[151]. - Adjusted EBITDA for the three months ended September 30, 2023, was $(3.9 million), compared to $(4,000) in 2022, indicating a deterioration in performance[160]. Business Operations and Strategy - The DeepView System has achieved a burn wound assessment accuracy of 92% for adults and 88% for pediatrics, significantly higher than the current physician accuracy of 50% to 75%[115]. - The company anticipates two revenue streams from the DeepView System: a software as a medical device (SaMD) model and an imaging device component[120]. - Future revenue may be impacted by the need to lower pricing and incentives to accelerate adoption of the DeepView System[137]. - The company expects to incur substantial additional expenses related to public company requirements following the business combination[128]. Market Activity - The company began trading its shares on NASDAQ under the symbols "MDAI" and "MDAIW" on September 12, 2023, following the business combination[124]. - The business combination was treated as a reverse recapitalization, with Legacy Spectral being treated as the accounting acquirer[126]. - Net cash used in operating activities increased by approximately $10.0 million for the nine months ended September 30, 2023, compared to the same period in 2022[166]. - Net cash provided by financing activities increased by approximately $4.7 million for the nine months ended September 30, 2023, primarily due to proceeds from an equity raise[167]. - The company entered into a financing arrangement for insurance premiums amounting to approximately $0.6 million, with an interest rate of 8.6% per annum[168]. Other Financial Metrics - The change in fair value of warrant liability increased by approximately $1.0 million for both the three and nine months ended September 30, 2023, compared to the same periods in 2022[153]. - Foreign exchange transaction loss for the three months ended September 30, 2023, was $(51,000), an increase of approximately 112.5% compared to $(24,000) in 2022[155]. - Transaction costs for the three months ended September 30, 2023, were $(7.6 million), compared to $(8.3 million) for the same period in 2022[156]. - As of September 30, 2023, the company had approximately $7.3 million in cash and an accumulated deficit of approximately $29.2 million[161].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ____________________________ FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 As filed with the Securities and Exchange Commission on October 30, 2023 Registration No. 333- ____________________________ Spectral AI, Inc. (Exact name of registrant as specified in its charter) ____________________________ | Delaware | 8731 | 85-3987148 | | --- | --- | --- | | (State or other jurisdiction of | (Primary Standard Industrial | ...