Strata Critical Medical, Inc.

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

Form 10-K

For the fiscal year ended: December 31, 2025

OR

For the transition period from to

Commission File Number 001-39046

(Exact name of registrant as specified in its charter)

(Registrant’s telephone number, including area code)

SECURITIES REGISTERED PURSUANT TO SECTION 12(b) OF THE ACT:

SECURITIES REGISTERED PURSUANT TO SECTION 12(g) OF THE ACT: NONE

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐No ☒

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Exchange Act. Yes ☐No ☒

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See definitions of “large accelerated filer”, “accelerated filer”, “smaller reporting company”, and “emerging growth company” in Rule 12b-2 of the Exchange Act:

If an emerging growth company, indicate by checkmark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to section 13(a) of the Exchange Act ☐

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.☒

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements.☐

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b–2 of the Exchange Act). Yes ☐ No☒

As of June 30, 2025, the last business day of the registrant’s most recently completed second fiscal quarter, the aggregate market value of the voting and non-voting common stock held by non-affiliates, computed by reference to the closing sales price of $4.03 per share, was approximately $263.9 million.

The Registrant had 86,989,143 shares of common stock outstanding as of February 24, 2026.

DOCUMENTS INCORPORATED BY REFERENCE

Portions of the registrant’s definitive proxy statement relating to its annual meeting of stockholders to be held in 2026, to be filed with the Securities and Exchange Commission (the “SEC”) within 120 days after the end of the fiscal year to which this Annual Report on Form 10-K relates, are incorporated herein by reference where indicated. Except with respect to information specifically incorporated by reference in this Annual Report on Form 10-K, such proxy statement is not deemed to be filed as part hereof.

FORM 10-K

TABLE OF CONTENTS

NOTE REGARDING FORWARD–LOOKING STATEMENTS AND RISK FACTOR SUMMARY

This Annual Report on Form 10-K may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements can generally be identified using forward-looking terminology, including the terms “believes”, “estimates”, “anticipates”, “expects”, “seeks”, “projects”, “intends”, plans”, “may”, “will” or “should” or, in each case, their negative or other variations or comparable terminology. These forward-looking statements include all matters that are not historical facts. They appear in several places throughout this report and include statements regarding our intentions, beliefs or current expectations concerning, among other things, results of operations, financial condition, liquidity, prospects, growth, strategies and the markets in which we operate. Such forward-looking statements are based on available current market material and management’s expectations, beliefs, and forecasts concerning future events impacting us and are inherently subject to significant business, economic and competitive uncertainties and contingencies, many of which are difficult to predict and generally beyond our control. Actual results and the timing of events may differ materially from the results anticipated in these forward-looking statements.

Our operations and financial results are subject to various risks and uncertainties. The following are among those factors, but are not the only factors, that could adversely affect us and/or that may cause actual results to differ materially from such forward-looking statements:

Risks Related to Our Business and Growth Strategy

•continued net losses or failure to achieve or maintain profitability;

•our ability to realize the anticipated benefits of strategic transactions, including the recently completed divestiture of the Passenger business, the acquisition and integration of Keystone (as defined below), and any future acquisitions or partnerships;

•harm to our reputation or brand arising from operational issues, public perception, clinical outcomes or actions of third parties;

•negative publicity, litigation, claims or regulatory scrutiny relating to our clinical services, perfusion staffing or organ recovery activities;

•our ability to provide high-quality customer support and maintain trusted relationships with Medical Customers;

•our reliance on contractual relationships with transplant centers, hospitals, Organ Procurement Organizations and strategic partners;

•adoption and effective utilization of our integrated clinical and logistics offerings by Medical Customers;

•competition within the transplant logistics, clinical services and organ preservation ecosystem;

•our dependence on the availability and utilization of donor organs and transplant volumes;

•insufficient reimbursement or funding for organ transport and related services;

•risks inherent in organ transportation operations, including delivery failures, operational disruptions or liability exposure;

•risks associated with ground transportation operations;

•advancements in preservation technology or alternative transport methods that could reduce demand for our services;

•aviation safety risks, including accidents, incidents or adverse publicity involving aircraft used in our operations;

•climate change, extreme weather events or environmental developments affecting our operations;

•terrorist attacks, geopolitical conflict or security events affecting aviation or healthcare infrastructure;

•volatility in aircraft fuel availability or cost;

•our ability to obtain additional capital or financing;

•restrictions under our Credit Agreement that may limit operational or strategic flexibility;

•our ability to manage growth, operational expansion and integration activities effectively;

•insurance market conditions, including increased premiums, reduced coverage availability or changes in underwriting standards;

•our dependence on key personnel and our ability to attract and retain qualified professionals;

•employment-related claims, workforce litigation or labor market challenges;

•our ability to maintain our company culture as we grow;

•fluctuations in financial results and the non-comparability of historical financial statements following discontinued operations;

•risks associated with purchasing aircraft or evolving from an asset-light model;

•risks associated with directly operating aircraft, including increased regulatory oversight, operational complexity or liability exposure;

•our reliance on maintaining efficient aircraft utilization to manage costs, operating efficiency and margins;

•changes in regulatory frameworks; and

•comparability of historical financial results due to the effects of discontinued operations for the Passenger business.

Risks Related to Our Dependence on Third-Party Providers

•our reliance on third-party aircraft operators to provide and operate aircraft used in our services;

•the availability of sufficient third-party aircraft capacity and our ability to add or retain operators to meet demand;

•workforce disruptions, operational interruptions or financial difficulties affecting third-party operators or service providers;

•reputational or operational risks arising from the illegal, improper or otherwise inappropriate operation of Strata-owned or Strata-branded aircraft by third-party operators; and

•our reliance on third-party cloud infrastructure, hosting providers and other technology vendors to support our systems and operations.

Risks Related to Intellectual Property, Cybersecurity, Information Technology and Data Management Practices

•interruptions, defects, failures or vulnerabilities in our technology systems or those of third-party providers;

•cybersecurity incidents, data breaches or misuse of artificial intelligence technologies that could disrupt operations or expose sensitive information;

•our ability to protect and enforce intellectual property rights; and

•risks associated with our use of open-source software.

Legal and Regulatory Risks Related to Our Business

•our operations within highly regulated aviation, healthcare and transplant environments, including evolving federal, state and local laws and regulations;

•the impact of any litigation or regulatory investigations that we may be subject to;

•our ability to comply with privacy, data protection, consumer protection and security laws; and

•the expansion of environmental regulations.

Other Risks

•our ability to remediate any material weaknesses or maintain effective internal controls over financial reporting;

•our ability to maintain effective disclosure controls and procedures; and

•the other factors described elsewhere in this Annual Report, included under the headings “Risk Factors,”

“Management’s Discussion and Analysis of Financial Condition” or as described in the other documents and

reports we file with the SEC.

Actual results, performance or achievements may differ materially, and potentially adversely, from any forward-looking statements and the assumptions on which those forward-looking statements are based. There can be no assurance that the data contained herein is reflective of future performance to any degree. You are cautioned not to place undue reliance on forward-looking statements as a predictor of future performance. All information set forth herein speaks only as of the date hereof and we disclaim any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this Annual Report on Form 10-K.

Unless the context indicates otherwise, references in this Annual Report on Form 10-K to the “Company”, “Strata”, “we”, “us”, “our”, and similar terms refer to Strata Critical Medical, Inc.