XML 34 R25.htm IDEA: XBRL DOCUMENT v3.25.3
Accounting Policies, by Policy (Policies)
 9 Months Ended
Sep. 30, 2025
Summary of Significant Accounting Policies [Abstract]  
Use of Estimates

Use of Estimates

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting periods. The most significant estimates in the Company’s condensed consolidated financial statements relate to accounting for acquisitions, valuation of inventory, estimates of future cash flows used to evaluate impairment of intangible assets, assumptions related to the pension benefit obligation, assumptions and accounting related to contingent warrant liabilities, warrant liabilities, and derivative liabilities, and accounting for income taxes. These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actual results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates and actual results, the Company’s future results of operations will be affected.
Segment Information

Segment Information

Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker (“CODM”), or decision-making group, in deciding how to allocate resources and in assessing performance. As of September 30, 2025 and December 31, 2024, the Company was operating in one segment: commercial. Management’s determination of its operating segments is consistent with the financial information regularly reviewed by the CODM for purposes of evaluating performance, allocating resources, setting incentive compensation targets, and planning and forecasting for future periods.
Fair Value Measurements

Fair Value Measurements

Fair value is defined as the price that would be received for sale of an asset or paid for transfer of a liability, in an orderly transaction between market participants at the measurement date. U.S. GAAP establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements). These tiers include:

  ● Level 1, defined as observable inputs such as quoted prices (unadjusted) for identical instruments in active markets;
  ● Level 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable such as quoted prices for similar instruments in active markets or quoted prices for identical or similar instruments in markets that are not active; and
  ● Level 3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions, such as valuations derived from valuation techniques in which one or more significant inputs or significant value drivers are unobservable.

In some circumstances, the inputs used to measure fair value might be categorized within different levels of the fair value hierarchy. In those instances, the fair value measurement is categorized in its entirety in the fair value hierarchy based on the lowest level input that is significant to the fair value measurement. Financial instruments, including cash, inventory, accounts receivable, accounts payable, accrued liabilities, operating lease liabilities, and notes payable are carried at cost, which management believes approximates fair value due to the short-term nature of these instruments.

The fair value of the contingent warrant liabilities, Series D warrant liabilities, Series D derivative liabilities and the related party subscription agreement liability are valued using significant unobservable measures and other fair value inputs and are therefore classified as Level 3 financial instruments.

The fair value of financial instruments measured on a recurring basis is as follows as of September 30, 2025 and December 31, 2024:

   As of September 30, 2025 
Description  Total   Level 1   Level 2   Level 3 
Liabilities:                
Contingent warrant liabilities  $53,149    
—
    
—
   $53,149 
Series D warrant liabilities  $12,815,000    
—
    
—
   $12,815,000 
Series D derivative liabilities  $988,000    
—
    
—
   $988,000 
Total  $13,856,149   $
—
   $
—
   $13,856,149 
    As of December 31, 2024  
Description   Total     Level 1     Level 2     Level 3  
Liabilities:                        
Contingent warrant liabilities   $ 43,089      
—
      
—
     $ 43,089  
Subscription agreement liability – Related Party   $ 4,123,000       —       —     $ 4,123,000  
Total   $ 4,166,089     $ —     $ —     $ 4,166,089  

During the year ended December 31, 2024, the Company recorded full impairments of the intangible assets acquired from the acquisitions of Proteomedix and ENTADFI. These non-financial assets had been valued using significant unobservable measures and other fair value inputs and were classified as Level 3 measurements.

None of the Company’s other non-financial assets or liabilities are recorded at fair value on a non-recurring basis as of September 30, 2025 and December 31, 2024. There were no transfers between levels during the periods presented.
Revenue Recognition

Revenue Recognition

The following is a description of principal activities from which the Company generates its revenue:

Development Services

Proteomedix provides a range of services to life sciences customers referred to as “Development Services” including testing for biomarker discovery, assay design and development. These Development Services are performed under individual statement of work (“SOW”) arrangements with specific deliverables defined by the customer. Development Services are generally performed on a time and materials basis. During the performance and through completion of the service to the customer in accordance with the SOW, the Company has the right to bill the customer for the agreed upon price and recognizes the Development Services revenue over the period estimated to complete the SOW. The Company generally identifies each SOW as a single performance obligation.

Completion of the service and satisfaction of the performance obligation under a SOW is typically evidenced by access to the data or test made available to the customer or any other form or applicable manner of delivery defined in the SOW. However, for certain SOWs under which work is performed pursuant to the customer’s highly customized specifications, the Company has the enforceable right to bill the customer for work completed, rather than upon completion of the SOW. For those SOWs, the Company recognizes revenue over a period of time during which the work is performed based on the expended efforts (inputs). As the performance obligation under the SOW is satisfied, any amounts earned as revenue and billed to the customer are included in accounts receivable.

Product Sales

The Company derives revenue through sales of its products, which includes Proclarix, its diagnostic product, directly to end users, including laboratories, hospitals, and medical centers, and to distributors. The Company considers customer purchase orders, which in some cases are governed by master sales agreements or standard terms and conditions, to be the contracts with a customer. For each contract, the Company considers the promise to transfer products, each of which is distinct, to be the identified performance obligations. In determining the transaction price, the Company evaluates whether the price is subject to refund or adjustment to determine the net consideration to which it expects to be entitled. The Company fulfills its performance obligation applicable to product sales once the product is transferred to the customer.

Other Revenue

The Company generates other revenue including license revenue through agreements that grant third parties rights to use its intellectual property and proprietary materials. In September 2025, the Company entered into a license agreement with Immunovia AB, under which it granted exclusive rights to certain intellectual property and transferred biological materials related to the PancreaSure™ test. The agreement included a non-refundable upfront payment of $300,000. Based on the terms of the agreement and the nature of the license, the Company determined that the performance obligations were satisfied upon the transfer of the licensed rights. Accordingly, the Company recognized the $300,000 as license revenue in the third quarter of 2025.

During the three months ended September 30, 2025 and 2024, the Company recognized revenue of approximately $0.3 million and $0.4 million, respectively.

During the nine months ended September 30, 2025 and 2024, the Company recognized revenue of approximately $0.5 million and $1.8 million, respectively.

The Company’s revenue was generated from the following geographic regions during the three months ended September 30, 2025: 

   European
Union		   Non-European
Union (UK)		   United
States		 
Development services   
—
%   
—
%   
—
%
Other revenue   100%   
—
%   
—
%
Product sales   
—
%   100%   
—
%
   European
Union		   Non-European
Union (UK)		   United
States		   Total
Revenue		 
Development services  $
—
   $
—
   $
—
   $
—
 
Other revenue   296,269    
—
    
—
    296,269 
Product sales   
—
    7,382   $
—
    7,382 
Total  $296,269   $7,382   $
—
   $303,651 

The Company’s revenue was generated from the following geographic regions during the nine months ended September 30, 2025: 

   European
Union		   Non-European
Union (UK)		   United
States		 
Development services   100%   
—
%   
—
%
Other revenue   100%   
—
%   
—
%
Product sales   93%   7%   
—
%
   European
Union		   Non-European
Union (UK)		   United
States		   Total
Revenue		 
Development services  $1,630   $
—
   $
—
   $1,630 
Other revenue   289,690    
—
    
—
    289,690 
Product sales   204,059    16,396    
—
    220,455 
Total  $495,379   $16,396   $
—
   $511,775 

The Company’s revenue was generated from the following geographic regions during the three months ended September 30, 2024:

   European
Union		   Non-European
Union (UK)		   United
States		 
Development services   100%   
—
%   
—
%
Product sales   
—
%   100%   
—
%
   European
Union		   Non-European
Union (UK)		   United
States		   Total
Revenue		 
Development services  $404,285   $
—
   $
—
   $404,285 
Product sales   
—
    2,574    
—
    2,574 
Total  $404,285   $2,574   $
—
   $406,859 

The Company’s revenue was generated from the following geographic regions during the nine months ended September 30, 2024:

   European
Union		   Non-European
Union (UK)		   United
States		 
Development services   100%   
—
%   
—
%
Product sales   
—
%   16%   84%
   European
Union		   Non-European
Union (UK)		   United
States		   Total
Revenue		 
Development services  $1,732,699   $
—
   $
—
   $1,732,699 
Product sales   
—
    12,711    66,730    79,441 
Total  $1,732,699   $12,711   $66,730   $1,812,140 

The Company had the following customer concentrations for its revenue during the three and nine months ended September 30, 2025 and 2024:

   For the Three Months Ended
September 30, 2025		   For the Nine Months Ended
September 30, 2025		 
   Development Services   Product
Sales		   Other
Revenue		   Development Services   Product
Sales		   Other
Revenue		 
Customer A   100%   
—
%   100%   100%   93%   100%
Customer C   —%   31%   —%   —%   2%   —%
Customer D   —%   69%    —%   
—
%   5%   —%
   For the Three Months Ended
September 30, 2024		   For the Nine Months Ended
September 30, 2024		 
   Development Services   Product
Sales		   Other
Revenue		   Development Services   Product
Sales		   Other
Revenue		 
Customer A   100%   
—
%   
—
%   100%   
—
%   
—
%
Customer B   
—
%   
—
%   
—
%   
—
%   84%   
—
%
Customer C   
—
%   70%   
—
%   
—
%   16%   
—
%
Customer D   
—
%   30%   
—
%   
—
%   
—
%   
—
%

Any revenues earned but not yet billed to the customer as of the date of the condensed consolidated financial statements are recorded as contract assets and are included in prepaid expenses and other current assets in the accompanying condensed consolidated financial statements. The Company had no unbilled accounts receivable as of September 30, 2025 and December 31, 2024. Amounts recorded in contract assets are reclassified to accounts receivable in our condensed consolidated financial statements when the customer is invoiced according to the billing schedule in the contract. Accounts receivable was approximately $3,000 and $26,000 as of September 30, 2025 and December 31, 2024, respectively.

In relation to customer contracts, the Company incurs costs to fulfill a contract but does not incur costs to obtain a contract. These costs to fulfill a contract do not meet the criteria for capitalization and are expensed as incurred.
New Accounting Pronouncements

New Accounting Pronouncements

There were no new accounting pronouncements issued since the Company’s filing of the Annual Report on Form 10-K for the year ended December 31, 2024, which could have a significant effect on the accompanying condensed consolidated financial statements.