40 added · 43 removed between the two most recent 10-Ks. The risks a company starts — or stops — disclosing are often the story.
Newly disclosed
In addition, the Company’s independent registered public accounting firm, in its report on the Company’s December 31, 2025 financial statements, raised substantial doubt about the Company’s ability to continue as a going concern.
We have limited control over the operations of these laboratories and can expect only limited amounts of time to be dedicated to our research goals. 21 Many of our business practices are subject to scrutiny and potential investigation by regulatory and government enforcement authorities, as well as to lawsuits brought by private citizens under federal and state laws.
The global market value of the IO sector—encompassing bispecific antibodies, cancer vaccines, checkpoint modulators, cell therapies, and oncolytic viruses—has reached an estimated $136 billion in 2025 and is projected to exceed $151 billion by the end of 2026, representing a monumental shift from the $29 billion valuation reported in 2019.
According to recent (early 2026) industry research form Global Data and Research and Markets, there are approximately 9,000 industry-sponsored clinical trials for immuno-oncology with more than 1,200 drugs in development.
Despite these efforts, we may not be successful in obtaining the necessary rights from all of them or these parties may breach the agreements and disclose our proprietary information.
While checkpoint modulators (specifically PD-1/PD-L1 inhibitors) remain the dominant category by revenue, the category of cancer vaccines has seen a resurgence due to breakthroughs in mRNA technology, with over 120 RNA-based vaccine trials currently active.
Our prior losses and expected future losses have had and will continue to have an adverse effect on our stockholders’ equity and working capital. 13 We will need additional capital to conduct our operations and develop our products, and our ability to obtain the necessary funding is uncertain.
Any failure to complete any stage of the development of products in a timely manner could have a material adverse effect on our operations, financial position and liquidity. 14 Risks Related to Clinical Development and Potential Regulatory Approval We have limited clinical testing and regulatory capabilities, and human clinical trials are subject to extensive regulatory requirements, which are very expensive, time-consuming and difficult to design and implement.
In addition, we or the FDA, may suspend our clinical trials at any time if it appears that we are exposing participants to unacceptable health risks or if the FDA finds deficiencies in our investigational new drug application, or IND, submissions or the conduct of these trials.
If we fail to commence or complete, or experience delays in, any of our planned clinical trials, our stock price and our ability to conduct our business as currently planned could be harmed. 15 If we experience delays or difficulties in the enrollment of patients in clinical trials, those clinical trials could take longer than expected to complete and our receipt of necessary regulatory approvals could be delayed or prevented.
If our license rights were restricted or ultimately lost, our ability to continue our business based on the affected technology platform could be severely adversely affected. 20 Risks Related to Our Business Operations and Industry If we lose key personnel, or if we cannot recruit qualified additional employees to carry on our business operations, we may not be able to implement our business strategy.
If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business and results of operations, including the imposition of significant fines or other sanctions.
No longer disclosed
Many of our business practices are subject to scrutiny and potential investigation by regulatory and government enforcement authorities, as well as to lawsuits brought by private citizens under federal and state laws.
The market value of bispecific antibodies, cancer vaccines, checkpoint modulators, cell therapies, and oncolytic viruses globally has increased sharply in the past 10 years with nearly $29 billion in 2019 compared to $370 million in 2010 .
According to Global Data, Thematic Research: Immuno-Oncology (March 2021), as of December 2020, there are 4,822 industry-sponsored clinical trials for immuno-oncology with 422 drugs in development.
As defined in Regulation 12b-2 under the Securities Exchange Act of 1934, or the Exchange Act, a “material weakness” is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented, or detected on a timely basis.
In any event, the process of determining whether our existing internal control over financial reporting is compliant with Section 404 of the Sarbanes-Oxley Act, or Section 404, and sufficiently effective requires the investment of substantial time and resources, including by certain members of our senior management.
However, for as long as we are a “smaller reporting company,” our independent registered public accounting firm will not be required to attest to the effectiveness of our internal control over financial reporting pursuant to Section 404.
Any product using any of our technology may fail to provide the intended therapeutic benefits or achieve therapeutic benefits equal to or better than the standard of treatment at the time of testing or production. 9 We have a history of operating losses and we expect to continue to incur losses for the foreseeable future and we may never generate revenue or achieve profitability.
While we could be a smaller reporting company for an indefinite amount of time, and thus relieved of the above-mentioned attestation requirement, an independent assessment of the effectiveness of our internal control over financial reporting could detect problems that our management’s assessment might not.
If our license rights were restricted or ultimately lost, our ability to continue our business based on the affected technology platform could be severely adversely affected. 13 We will have to hire additional employees to carry on our business operations.
If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business and results of operations, including the imposition of significant fines or other sanctions. 14 Our reliance on the activities of our non-employee consultants, research institutions and scientific contractors, whose activities are not wholly within our control, may lead to delays in development of our proposed products.
We are subject to extensive regulation, which can be costly and time consuming and can subject us to unanticipated delays. even if we obtain regulatory approval for some of our products, those products may still face regulatory difficulties.
In addition, if we or others identify side effects after any of our adoptive therapies are on the market, or if manufacturing problems occur, regulators may withdraw their approval and reformulations, additional clinical trials, changes in labeling of our products, and additional marketing applications may be required.