8-K: Profusa, Inc. Changes Independent Auditors Amidst Financial Concerns

Profusa, Inc. has dismissed CBIZ CPAs P.C. as its independent auditor and engaged WithumSmith+Brown, PC, following disclosures of material weaknesses and substantial doubt about its ability to continue as a going concern.

Summary

• Profusa, Inc. announced on October 5, 2026, the dismissal of its independent registered public accounting firm, CBIZ CPAs P.C. (CBIZ).
• The decision was approved by the Company's Audit Committee and Board of Directors.
• CBIZ's report for the fiscal year ended December 31, 2025, included an explanatory paragraph expressing substantial doubt about the Company's ability to continue as a going concern.
• During the past two fiscal years and the interim period through October 5, 2026, there were no disagreements with CBIZ on accounting principles or financial statement disclosures.
• However, there were reportable events related to material weaknesses in internal control over financial reporting, including issues with segregation of duties, valuation of financial instruments, and preparation of financial statements in accordance with U.S. GAAP.
• These material weaknesses had not been remediated as of June 30, 2026.
• On September 30, 2026, the Audit Committee approved the engagement of WithumSmith+Brown, PC (Withum) as the new independent registered public accounting firm.
• The engagement of Withum was approved by the Board and became effective on October 6, 2026, for the fiscal year ending December 31, 2026.

Sentiment

Score: 3

Explanation: StockSavvy.ai views this as a negative development due to the change in auditors coinciding with previously disclosed material weaknesses and going concern issues.

Positives

• The company has proactively engaged a new accounting firm, WithumSmith+Brown, PC, to provide independent audit services for the upcoming fiscal year.
• The change in auditors was approved by both the Audit Committee and the Board of Directors, indicating a formal governance process was followed.

Negatives

• The company's previous auditor, CBIZ, issued a report for the fiscal year ended December 31, 2025, which included an explanatory paragraph expressing substantial doubt about Profusa, Inc.'s ability to continue as a going concern.
• Material weaknesses in internal control over financial reporting were identified and had not been remediated as of June 30, 2026.
• These weaknesses relate to segregation of duties, valuation of financial instruments, and the accurate preparation of financial statements under U.S. GAAP, particularly concerning complex debt and equity instruments.

Risks

• The substantial doubt about the Company's ability to continue as a going concern, as noted by the previous auditor, remains a significant risk.
• The un-remediated material weaknesses in internal controls could lead to future financial misstatements or operational inefficiencies.
• The transition to a new auditor may introduce temporary disruptions or require additional resources to ensure a smooth audit process.

Future Outlook

The filing does not contain specific forward-looking statements or guidance. However, the engagement of a new auditor for the fiscal year ending December 31, 2026, indicates the company is proceeding with its financial reporting obligations.

Management Comments

• The decision to change the Company's independent registered public accounting firm was approved by the Company's Audit Committee and Board of Directors.
• The Company has authorized CBIZ to respond fully to the inquiries of the successor independent registered public accounting firm concerning the material weaknesses.

Industry Context

StockSavvy.ai notes that changes in auditors, especially when coupled with previously disclosed going concern warnings and material weaknesses, can be a signal of underlying financial or operational challenges. Companies often change auditors to gain a fresh perspective or if there are disagreements, though this filing states no such disagreements occurred.

Corporate Governance

Stakeholder Impact

• Shareholders: The change in auditors, coupled with prior going concern and material weakness disclosures, may increase investor scrutiny and potentially impact stock price volatility.
• Creditors: The ongoing concerns about the company's ability to continue as a going concern and the effectiveness of its internal controls could affect lender confidence.
• Employees: Uncertainty surrounding the company's financial health may impact employee morale and confidence in the company's future.

Next Steps

• WithumSmith+Brown, PC will serve as the independent registered public accounting firm for the fiscal year ending December 31, 2026.
• The company will continue to address and work towards remediating the previously disclosed material weaknesses in its internal control over financial reporting.

Key Dates

Recommendation

The filing highlights significant concerns regarding the company's financial health, including a going concern warning and material weaknesses in internal controls. While the change in auditors is a procedural step, it does not resolve these underlying issues. The company's ability to remediate these weaknesses and regain financial stability is critical. Therefore, a 'hold' recommendation is appropriate pending further clarity on operational improvements and financial performance.

Keywords

Change of Accountant, Independent Auditor, Material Weaknesses, Internal Controls, Going Concern, Financial Reporting, Audit Committee, Form 8-K