10-K: Mosaic ImmunoEngineering Faces Funding Crisis, Delays Oncotelic Deal

Sentiment:

Annual Report


Mosaic ImmunoEngineering's 10-K filing reveals significant going concern risks due to insufficient working capital and ongoing discussions for a potential acquisition of Oncotelic's technologies, which could lead to substantial dilution.

Delay expectedThe binding term sheet with Oncotelic Therapeutics, Inc. expired on June 30, 2025, indicating a delay or potential failure in reaching a definitive agreement for acquisition and funding.The company's development efforts have been limited and scaled back due to insufficient funds, implying delays in advancing any potential product candidates.The termination of the CWRU license agreement suggests a delay or halt in the development of the MIE-101 candidate due to financial constraints.
Capital raiseThe company explicitly states it needs "substantial additional funding" and that its "cash on hand will not satisfy its operational and capital requirements through twelve months from the filing date."The company plans to "continue to fund losses from operations and future funding needs through our cash on hand and future potential equity and/or debt offerings."The binding term sheet with Oncotelic included provisions for Oncotelic to assist the company in potentially raising initial funding of $2 million.The company entered into a convertible note purchase agreement with an accredited investor for up to $200,000 in November 2024.The company acknowledges that raising funds from equity securities will be challenging and likely result in substantial dilution.The company acknowledges that debt financing is also challenging and may involve significant cash payment obligations and restrictive covenants.
Worse than expectedThe company explicitly states "substantial doubt about our ability to continue as a going concern" due to insufficient working capital and ongoing operating losses.The company has no current development pipeline and may not successfully identify, license, or acquire new product candidates.The binding term sheet with Oncotelic Therapeutics, Inc. expired, creating uncertainty about a critical potential acquisition and funding source.The company's cash and cash equivalents are extremely low ($3,622 as of December 31, 2025), indicating a severe liquidity crisis.The license agreement with CWRU was terminated due to non-payment of fees, indicating operational and financial distress.

Summary

  • Mosaic ImmunoEngineering, Inc. (Mosaic) is a development-stage biotechnology company focused on cancer immunotherapies.
  • The company faces substantial doubt about its ability to continue as a going concern due to insufficient working capital to fund operations for the next twelve months.
  • Mosaic has incurred operating losses since inception and has limited cash and equivalents ($3,622 as of December 31, 2025).
  • A binding term sheet was entered into with Oncotelic Therapeutics, Inc. on April 26, 2024, to acquire certain cancer therapies and AI technologies. This deal, valued at $15 million, is subject to conditions including shareholder approval and waivers from convertible noteholders.
  • The binding term sheet expired on June 30, 2025, but discussions are ongoing. If a definitive agreement is reached, existing stockholders would experience substantial dilution, with up to 47,923,322 shares potentially issued to Oncotelic.
  • The company has no current development pipeline and may not successfully identify, license, or acquire new product candidates.
  • Mosaic's historical license agreement with Case Western Reserve University (CWRU) for the CPMV platform technology was terminated on March 22, 2024, due to the company's inability to pay accrued patent fees.
  • The company has two full-time and five part-time employees, with most being inactive due to insufficient capital.
  • The company's common stock is quoted on the OTC Pink Open Market under the symbol CPMV, with limited liquidity and high volatility.

Sentiment

Score: 1

Explanation: StockSavvy.ai views this filing as extremely negative due to the severe going concern risks, lack of a development pipeline, expired critical acquisition term sheet, and extremely low cash reserves, indicating a high probability of operational cessation without immediate and substantial funding.

Positives

  • Discussions with Oncotelic Therapeutics, Inc. are ongoing, indicating potential for a future technology acquisition and short-term funding.
  • The company has a strategy to leverage industry experience to identify, develop, and commercialize immunotherapies.
  • The company has a management team with scientific and business advisors experienced in immunotherapy.
  • The company has entered into a Master Services Agreement with Oncotelic, earning $14,000 in 2025 for advisory services.

Negatives

  • Substantial doubt exists about the company's ability to continue as a going concern due to insufficient working capital and ongoing operating losses.
  • The company has no current development pipeline and may not successfully identify, license, or acquire new product candidates.
  • The binding term sheet with Oncotelic expired on June 30, 2025, creating uncertainty about the potential acquisition.
  • If the Oncotelic deal proceeds, existing stockholders will face substantial dilution.
  • The license agreement with Case Western Reserve University (CWRU) was terminated due to non-payment of patent fees.
  • The company has very limited cash and cash equivalents ($3,622 as of December 31, 2025).
  • The company has limited insurance coverage for its operations.
  • The company's common stock is illiquid and subject to penny stock rules, potentially limiting capital raising efforts.
  • There is a material weakness in internal control over financial reporting due to a lack of segregation of duties.

Risks

  • The company does not currently have sufficient working capital to fund its existing liabilities or planned operations for the next twelve months and may be required to cease operations altogether if sufficient funding is not secured.
  • There is substantial doubt about the company's ability to continue as a going concern.
  • The binding term sheet with Oncotelic Therapeutics, Inc. expired on June 30, 2025, and there is no guarantee a definitive agreement will be reached.
  • If a definitive agreement with Oncotelic is entered into, existing stockholders will experience substantial immediate dilution.
  • The company currently has no development pipeline and may not successfully identify, license, or acquire new product candidates.
  • If the company raises sufficient capital and identifies new product candidates, it expects to incur significant losses over the next several years and may never achieve or maintain profitability.
  • The company's short operating history may make it difficult to evaluate its success and future viability.
  • The company and its subsidiaries have limited insurance for their operations and are subject to various risks of loss.
  • Drug development involves a lengthy and expensive process with an uncertain outcome, including potential failure to demonstrate safety and efficacy.
  • The company may incur additional costs or experience delays in completing product manufacturing.
  • Serious adverse events or unacceptable side effects identified during development could lead to abandonment or limitation of product candidates.
  • The company's common stock has substantial lack of liquidity and volatility risks, and there is no active public trading market.
  • The market for the company's common stock is subject to penny stock rules, which may limit its ability to raise capital.
  • Future sales of shares by existing stockholders could cause the company's stock price to decline.
  • The company expects its stock price to be volatile, and the market price may drop unexpectedly.
  • The company may issue preferred stock, the terms of which could reduce the value of its common stock.
  • The company's executive officers, directors, and principal stockholders, if acting together, have the ability to control all matters submitted to stockholders for approval.
  • The company's amended and restated certificate of incorporation and bylaws designate Delaware state or federal courts as the sole and exclusive forum for substantially all disputes between the company and its stockholders.
  • Anti-takeover provisions in the company's charter documents and Delaware law could impair a takeover attempt.
  • The company's business and operations would suffer in the event of computer system failures, cyber-attacks, or deficiencies in cybersecurity.
  • If the company fails to establish and maintain proper and effective internal control over financial reporting, its operating results and ability to operate could be harmed.
  • The company's net operating loss carryforwards may be subject to limitations under Section 382 of the Internal Revenue Code.
  • Reliance on third parties for manufacturing, development, and data provision introduces risks of delays, quality issues, and inaccurate information.
  • The company may be unable to obtain or maintain intellectual property protection for its technologies or products.
  • Third parties may initiate legal proceedings alleging infringement of their intellectual property rights.
  • The company may need to license intellectual property from third parties, and such licenses may not be available on commercially reasonable terms.
  • The company's future success depends on its ability to attract, hire, retain, and motivate executives and key employees.
  • The company may encounter difficulties in managing growth, which could disrupt its operations.
  • The company may face risks related to securities litigation.
  • The company has no properties and uses management's home offices at no cost.
  • The company has no sales, marketing, or commercialization capabilities.

Future Outlook

The company anticipates significant losses over the next several years and may never achieve or maintain profitability. Its ability to continue operations is highly dependent on raising substantial additional capital, which is uncertain. The company expects to retain future earnings, if any, to fund development and growth, and does not expect to pay cash dividends in the foreseeable future.

Management Comments

  • "While the Companys financial statements have been prepared on a going concern basis, we do not currently have sufficient working capital to fund our current liabilities and planned operations for the next twelve months and we may be required to cease our operations altogether if we are unable to secure sufficient funding."
  • "We currently have no development pipeline and we may not successfully identify, license or acquire new product candidates."
  • "If we are able to raise sufficient capital and successfully identify new product candidates, we expect that we will incur significant losses over the next several years and may never achieve or maintain profitability."
  • "Our ability to continue our operations is highly dependent on our ability to raise capital to fund future operations."
  • "The above matters raise substantial doubt regarding our ability to continue as a going concern."

Industry Context

StockSavvy.ai notes that Mosaic ImmunoEngineering operates in the highly competitive and capital-intensive biotechnology sector, specifically focusing on immunotherapies for cancer. The company's current financial precariousness and lack of a developed pipeline place it at a significant disadvantage compared to larger, established players with substantial R&D budgets and commercial infrastructure.

Comparison to Industry Standards

  • The company's cash position of $3,622 as of December 31, 2025, is significantly below the typical operating capital required for even early-stage biotechnology companies, which often require hundreds of millions of dollars to advance a drug candidate through clinical trials.
  • The lack of a development pipeline is a critical deviation from industry standards, where companies typically maintain a portfolio of preclinical and clinical-stage assets to mitigate risk and ensure future growth.
  • The termination of the CWRU license agreement due to non-payment of patent fees highlights a failure to meet basic operational obligations, which is uncommon for companies actively pursuing drug development.
  • The company's reliance on home offices and limited personnel (two full-time, five part-time) contrasts sharply with the larger teams and specialized facilities common in the biotech industry.

Management Changes

RolePrevious PersonNew PersonEffective DateReason
Chief Financial OfficerPaul LytleSteven King2025-08-15Resignation of Paul Lytle
EVP, CFO and Board positionPaul LytleN/A2025-08-15Resignation

Corporate Governance

Change TypeDescriptionEffective DateImpact Assessment
Board CompositionDue to the company's size, limited operations, and limited cash on hand, the Board of Directors consisted of only one Director as of December 31, 2025.2025-12-31Lack of independent directors and limited board oversight may pose governance risks.
Internal ControlsA material weakness exists due to a lack of segregation of duties within the organization's internal control structure over financial reporting.2025-12-31Increases the risk of errors or fraud in financial reporting.
Director IndependenceAs Steven King is the sole Board member, the company does not have an independent director within the meaning of Nasdaq Marketplace Rule 5605(a)(2).2025-12-31Potential lack of objective oversight and independent judgment in board decisions.
Insider Trading PolicyThe company does not maintain specific insider trading policies and procedures due to a limited number of directors, officers, and employees.2025-12-31Increases the risk of potential violations of insider trading laws.

Legal Proceedings

  • The company may be involved in various lawsuits and claims arising in the ordinary course of business, including actions with respect to intellectual property, employment, and contractual matters. However, as of December 31, 2025, the company is not involved in any litigation.
  • A claim regarding 5,690 escrow shares of common stock related to the acquisition of Crossflo is pending resolution. The company believes it is probable that the resolution will not result in a material obligation, but there is no assurance.

Related Party Transactions

  • Consulting agreements were in place with Nicole Steinmetz, Ph.D., Jonathan Pokorski, Ph.D., and Steve Fiering, Ph.D. (co-founders and >5% shareholders) for scientific contributions. No related party consulting expenses were incurred in 2025 or 2024.
  • Deferred consulting payments to these related parties are to be compensated with Restricted Stock Units (RSUs) upon future financing.
  • Three former Board members and one current Board member invested in convertible notes issued in May 2021 and February 2022.
  • Steven King, President and CEO, is a shareholder and board member of Oncotelic Therapeutics, Inc. (less than 1% ownership) and a paid advisor.

Stakeholder Impact

  • Shareholders face significant risk of dilution if the Oncotelic deal proceeds and a high risk of losing their entire investment due to the going concern issues.
  • Employees (two full-time, five part-time) may face job insecurity due to the company's financial situation and potential cessation of operations.
  • Creditors and suppliers may face delayed or non-payment of outstanding liabilities due to the company's liquidity crisis.

Next Steps

  • Continue discussions with Oncotelic Therapeutics, Inc. regarding a potential definitive agreement.
  • Seek substantial additional capital through equity or debt offerings to fund operations and development.
  • Identify, license, or acquire new product candidates to build a development pipeline.
  • Implement broader cybersecurity measures once sufficient capital is raised.
  • Potentially build necessary capabilities and infrastructure for commercialization if product candidates advance.

Key Dates

DateDescription
2020-03-30Private Mosaic, a Delaware corporation, was formed.
2020-07-01Material Transfer, Evaluation, and Exclusive Option Agreement (License Option Agreement) signed with Case Western Reserve University (CWRU).
2020-08-19Patriot Scientific Corporation (now Mosaic ImmunoEngineering, Inc.) and Private Mosaic entered into a stock purchase agreement for a reverse merger.
2020-08-21Closing Date of the Reverse Merger.
2020-11-03Code of Business Conduct and Ethics adopted.
2020-11-30Amended and restated articles of incorporation filed to change the company name and implement a reverse stock split.
2020-12-02Reverse Stock Split effective.
2020-12-30Fiscal year end changed from May 31 to December 31.
2021-05-07Issued unsecured convertible promissory notes in the aggregate principal amount of $575,000.
2021-07-01Entered into a licensing agreement with UC San Diego for technology involving immuno-stimulatory molecules.
2021-09-01Consulting agreements with Related Parties became effective (retroactive).
2022-02-18Issued unsecured convertible promissory notes in the aggregate principal amount of $341,632.
2022-05-04Entered into the license agreement with CWRU.
2023-07-06Entered into a redemption agreement with Holocom, Inc.
2024-03-22Received notice of termination from CWRU for the License Agreement.
2024-04-26Entered into a binding term sheet with Oncotelic Therapeutics, Inc.
2024-05-08Entered into a convertible note purchase agreement with Oncotelic for up to $70,000.
2024-05-10Selected Rose, Snyder & Jacobs LLP as new independent registered public accounting firm.
2024-05-21KMJ Corbin & Company LLP resigned as independent registered public accounting firm.
2024-07-01Entered into a Master Services Agreement with Oncotelic.
2024-11-18Entered into an unsecured convertible promissory note (Note Purchase Agreement) with an accredited investor for up to $200,000.
2024-12-04Received $200,000 under the note purchase agreement.
2024-12-12Repaid the entire outstanding principal of $70,000 and accrued interest to Oncotelic.
2025-02-28Master Services Agreement with Oncotelic expired.
2025-06-30Binding Term Sheet with Oncotelic expired.
2025-08-15Paul Lytle resigned as EVP, CFO; Steven King assumed the role of CFO.
2025-12-31Fiscal year end.
2026-04-15Date of filing for the Form 10-K.

Recommendation

sell

The company is facing severe going concern risks, with insufficient capital to operate for the next twelve months. The lack of a development pipeline, the expiration of a critical acquisition term sheet with Oncotelic, and the substantial dilution risk associated with any potential deal make the investment highly speculative and precarious. The extremely low cash reserves and the explicit statement of doubt about continuing as a going concern strongly suggest a sell recommendation.

Keywords

Mosaic ImmunoEngineering, 10-K, Biotechnology, Immunotherapy, Cancer Treatment, SEC Filing, Going Concern, Funding, Oncotelic Therapeutics, Dilution, Clinical Stage, Biotech, Startup

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