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Mon Oct 26 · pre-market1 signal on Oct 2494 insider buys this week · $48.3MCIRO short report next: Oct 31The week ahead

CPMV

Mosaic ImmunoEngineering Inc.
OTC · HEALTH CARE · BIOLOGICAL PRODUCTS, (NO DIAGNOSTIC SUBSTANCES)
0.06
+0.00 +0.00%
USD · close Oct 23

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How CPMV rewrote its risk factors

10-K ITEM 1A · FY2024 → FY2025
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New in FY2025

  • Risk Factors” and “Item 7 – Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in Part II.
  • You should read this report completely with the understanding that our actual results may differ materially from what we expect.
  • Unless required by law, we undertake no obligation to publicly disclose the result of any revision of these forward-looking statements to reflect events or circumstances after the date they are made or to reflect the occurrence of unanticipated events.
  • You should not place undue reliance on these types of forward-looking statements, which speak only as of the date that they were made.
  • These forward-looking statements are based on the beliefs and assumptions of the Company’s management based on information currently available to management and should be considered in connection with any written or oral forward-looking statements that the Company may issue in the future as well as other cautionary statements the Company has made and may make.
  • Except as required by law, the Company does not undertake any obligation to release publicly any revisions to these forward-looking statements after completion of the filing of this Report to reflect later events or circumstances or the occurrence of unanticipated events. ii RISK FACTOR SUMMARY Below is a summary of material factors that make an investment in our common stock speculative or risky.
  • Importantly, this summary does not address all of the risks and uncertainties that we face.
  • You should understand that it is not possible to predict or identify all such factors.
  • Consequently, you should not consider this section to be a complete discussion of all potential risks or uncertainties that may substantially impact our business.
  • Additional discussion of the risks and uncertainties summarized in this risk factor summary, as well as other risks and uncertainties that we face, can be found under “ Risk Factors ” in Part I, Item 1A of this Report.
  • Moreover, we operate in a competitive and rapidly changing environment.
  • New factors emerge from time to time, and it is not possible to predict the impact of all of these factors on our business, financial condition or results of operations.
  • The below summary is qualified in its entirety by that more complete discussion of such risks and uncertainties.
  • You should consider carefully the risks and uncertainties described under “ Risk Factors ” in Part I, Item 1A of this Report as part of your evaluation of an investment in our common stock.
  • Risks Related to Our Operations · While the Company’s 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 entered into a binding term sheet with Oncotelic Therapeutics, Inc. to acquire rights to certain technologies of Oncotelic and we may not enter into a definitive agreement if certain conditions are not met.
  • The Binding Term Sheet expired on June 30, 2025.
  • The ongoing discussions may not yield an agreement. · If we enter into a definitive agreement with Oncotelic under the terms of the binding term sheet, existing stockholders will experience substantial immediate dilution. · 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 development efforts have historically been with product candidates in early-stage preclinical development. · Our short operating history may make it difficult to evaluate the success of our business to date and to assess our future viability. · The Company and its subsidiaries have limited insurance for their operations and are subject to various risks of loss. · If we successfully identify new product candidates and license those rights, then drug development will involve a lengthy and expensive process with an uncertain outcome, including failure to demonstrate safety and efficacy to the satisfaction of the FDA or similar regulatory authorities outside the United States.
  • We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the product manufacturing of any potential product candidates. · If serious adverse events or unacceptable side effects are identified during the development of any new product candidates, we may need to abandon or limit our development of those future product candidates.
  • Risks Related to Our Financial Position and Need for Additional Capital · We need substantial additional funding.
  • If we are unable to secure sufficient capital in the near term, we may be required to cease operations. · Raising capital will cause dilution to our stockholders, restrict our operations, or require us to relinquish rights to our technologies or product candidates.
  • Risks Related to Our Dependence on Third Parties · If we successfully identify new product candidates and license those rights, then future development collaborations may be important to us.
  • If we are unable to enter or maintain these collaborations, or if these collaborations are not successful, our business could be adversely affected. · We may contract with third parties for the manufacture of product candidates for preclinical and clinical studies and may expect to continue to do so for commercialization.
  • This potential reliance on third parties increases the risk that we will not have sufficient product supplies of our candidates or products at an acceptable cost and quality, which could delay, prevent or impair our development or commercialization efforts. · Data provided by collaborators and other parties upon which we rely has not been independently verified and could turn out to be inaccurate, misleading, or incomplete. iii Risks Related to Intellectual Property · If we are unable to obtain and maintain intellectual property protection for technology and products we plan to license or develop or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize technology and products similar or identical to ours, and our ability to successfully commercialize our technology and products may be impaired. · If we successfully identify new product candidates and license those rights, we may fail to comply with our obligations under any potential license agreement in which we may license intellectual property and other rights from third parties or otherwise experience disruptions to our business relationships with our future licensors, and we could lose those rights or other rights, which could be the products upon which our business depends. · If we successfully identify new product candidates and license those rights, we may become involved in lawsuits to protect or enforce those patents or other intellectual property, which could be expensive, time consuming and unsuccessful. · We may need to license certain intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms. · Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business. · If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • Risks Related to Our Employee Matters, Managing Growth and Macroeconomic Conditions · If we successfully identify new product candidates and license those rights, then our future success will also depend on our ability to attract, hire, retain and motivate executives, key employees, and our general workforce. · If we successfully identify new product candidates and license those rights, then we expect to expand our research and development function, as well as our corporate operations, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations. · We may face risks related to securities litigation that could result in significant legal expenses and settlement or damage awards.
  • Risks Related to Our Common Stock · There is a substantial lack of liquidity of our common stock and volatility risks, and because there is no active public trading market for our common stock, you may not be able to resell your common stock. · The market for our common stock is subject to rules relating to low-priced stock (“Penny Stock”) which may limit our ability to raise capital. · Future sales of shares by existing stockholders could cause the Company’s stock price to decline. · We expect our stock price to be volatile, and the market price of our common stock may drop unexpectedly. · We may issue preferred stock, and the terms of such preferred stock may reduce the value of our common stock. · Our executive officers, directors and principal stockholders, if they choose to act together, will have the ability to control all matters submitted to stockholders for approval. · Our amended and restated certificate of incorporation and amended and restated bylaws provides that state or federal court located within the state of Delaware will be the sole and exclusive forum for substantially all disputes between us and our stockholders, which could limit its stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or other employees. · Anti-takeover provisions contained in our amended and restated certificate of incorporation and amended and restated bylaws, as well as provisions of Delaware law, could impair a takeover attempt. iv PART I Unless the context otherwise requires, references to the “Company,” “Mosaic,” “we,” “our,” or “us” in this Annual Report on ITEM 1.
  • BUSINESS Business Overview We are a development-stage biotechnology company focused on advancing and eventually commercializing immunotherapies for the treatment of cancer.
  • We have historically advanced early-stage product candidates and we are pursuing new product candidates and platforms to build a product pipeline based on our deep understanding of immunotherapies.
  • Business Strategy Our strategy is to leverage our considerable industry experience, understanding of immunotherapies, and development expertise to identify, develop and commercialize product candidates with significant market potential that can fulfill unmet medical needs in the treatment of cancer.
  • We have assembled a management team along with both scientific and business advisors, including recognized experts in the field of immunotherapy, with significant industry and regulatory experience to lead and execute the development and commercialization of immunotherapy products.
  • We are focused on identifying and successfully licensing or acquiring new product candidates.
  • As part of our strategy, on April 26, 2024, we entered into a binding term sheet (“Binding Term Sheet”) with Oncotelic Therapeutics, Inc.(“Oncotelic”) pursuant to which we intend to acquire (i) certain rights to Oncotelic’s clinical stage necroptosis cancer therapies associated with its vascular disruptive agents (“VDAs”) and related regulatory and clinical packages, and (ii) non-exclusive access to its proprietary Artificial Intelligence (“AI”) technologies for identifying immunotherapy combinations, in exchange for shares of our common stock valued at $15.0 million upon execution of the definitive agreement, or a combination of common stock and preferred stock to be determined by the parties, along with additional milestones allowing Oncotelic to earn up to an additional $15.0 million in shares of common stock that would be valued at the time of issuance, if earned.
  • Pursuant to the Binding Term Sheet, we and Oncotelic agreed to negotiate in good faith towards the execution of a definitive agreement and the closing of the transaction, which is subject to customary due diligence and other conditions, including obtaining shareholder approval for the transaction and receiving waivers from our holders of Convertible Notes representing at least 90% of the principal amount outstanding from any payment that would become due and payable upon a corporate transaction as contemplated under the Binding Term Sheet.
  • The Binding Term Sheet expired on June 30, 2025 however discussions are ongoing that will allow us to bring in a technology portfolio to achieve our goals.
  • Our Corporate History and Background Private Mosaic, a Delaware corporation, was formed on March 30, 2020.
  • On May 4, 2022, we entered into the license agreement with CWRU (“License Agreement”) pursuant to our rights granted under the License Option Agreement (see Note 5 to the accompanying audited consolidated financial statements), which was terminated on March 22, 2024.
  • Each share of Series A Preferred was converted into 10.194106 shares of common stock as defined in the Series A Certificate of Designation.
  • On May 7, 2021 and February 18, 2022, we issued unsecured convertible promissory notes in the aggregate principal amount of $575,000 and $341,632, respectively (see Note 6 to the accompanying consolidated financial statements).
  • Amounts totaling $70,000 were received at various times during the year ended December 31, 2024.
  • As of December 31, 2024, there were no amounts due or outstanding under the convertible note purchase agreement with Oncotelic.
  • During the years ended December 31, 2025 and 2024, we earned $14,000 and $42,000, respectively, for advisory and related services which is recorded in other income in the accompanying consolidated statements of operations.

and 420 more.

Gone since FY2024

  • Risk Factors for a discussion of certain risk factors applicable to our business, financial condition, and results of operations.
  • Operating results are not necessarily indicative of results that may occur for any future period.
  • Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.
  • Overview We are a development-stage biotechnology company focused on advancing and eventually commercializing immunotherapies for the treatment of cancer.
  • We have historically advanced early-stage product candidates and we are pursuing new product candidates and platforms to build a new pipeline based on a deep understanding of immunotherapies.
  • Summary of Significant Events Private Mosaic, a Delaware corporation, was formed on March 30, 2020.
  • On May 4, 2022, we entered into the license agreement with CWRU (“License Agreement”) pursuant to our rights granted under the License Option Agreement (see Note 6 to the accompanying audited consolidated financial statements).
  • On March 22, 2024, we received a notice of termination from CWRU (see Note 6 to the accompanying consolidated financial statements).
  • Each share of Series A Preferred converted into 10.194106 shares of common stock as defined in the Series A Certificate of Designation.
  • On May 7, 2021 and February 18, 2022, we issued unsecured convertible promissory notes in the aggregate principal amount of $575,000 and $341,632, respectively (see Note 7 to the accompanying consolidated financial statements).
  • On July 6, 2022, we entered into a redemption agreement (the “Redemption Agreement”) with Holocom, Inc.
  • (“Holocom”) pursuant to which we requested full redemption of our 2,100,000 shares of Series A Preferred Stock at a redemption price of $0.40 per share, provided Holocom has sufficient capital to redeem the underlying shares.
  • As of December 31, 2023, we redeemed in aggregate, 2,100,000 shares of Series A Preferred Stock, in exchange for aggregate net proceeds received by us of $776,000 (see Note 4 to the accompanying consolidated financial statements).
  • As of December 31, 2023, Holocom had no further obligations to us under the Redemption Agreement or any other arrangement and therefore there were no proceeds received during the year ended December 31, 2024.
  • On April 26, 2024, we entered into a binding term sheet (“Binding Term Sheet”) with Oncotelic Therapeutics, Inc.
  • (“Oncotelic”) pursuant to which we intend to acquire (i) certain rights to Oncotelic’s clinical stage necroptosis cancer therapies associated with its vascular disruptive agents (“VDAs”) and related regulatory and clinical packages, and (ii) non-exclusive access to its proprietary Artificial Intelligence (“AI”) technologies for identifying immunotherapy combinations, in exchange for the issuance of shares of our common stock valued at $15.0 million upon execution of the definitive agreement (representing 47,923,322 shares of our common stock), or a combination of common stock and preferred stock to be determined by the parties, along with additional milestones allowing Oncotelic to earn up to an additional $15.0 million in shares of common stock that would be valued at the time of issuance, if earned.
  • Pursuant to the Binding Term Sheet, we and Oncotelic agreed to negotiate in good faith towards the execution of a definitive agreement and the closing of the transaction within ninety (90) days, which is subject to customary due diligence and other conditions, including us obtaining shareholder approval for the transaction and receiving waivers from our holders of Convertible Notes representing at least 90% of the principal amount outstanding from any payment that would become due and payable upon a corporate transaction as contemplated under the Binding Term Sheet.
  • In addition, under the Binding Term Sheet, (i) we will continue the development work necessary to achieve the mutually agreed upon milestones upon the requisite funding, (ii) Oncotelic will provide a loan to us to cover certain operational costs of the Company initially through June 2024, (iii) Oncotelic will assist the Company in potentially raising initial funding to support the technologies of $2 million, and (iv) in the event the Company is unable to raise the requisite funding, then the transaction may proceed to a reverse acquisition/merger, with conditions typical of such a transaction.
  • If we enter into a definitive agreement under the terms of the Binding Term Sheet, our present stockholders will experience immediate substantial dilution and will not have control of our majority voting securities.
  • In addition, if we do not receive shareholder approval for a possible transaction by Juen 30, 2025, as amended, we may not be able to enter into a definitive agreement with Oncotelic, and we may need to cease our operations altogether.
  • Currently, we and Oncotelic are continuing to pursue a potential transaction under the Binding Term Sheet although there are no guarantees we will enter into any definitive agreement.
  • On December 31, 2024, the expiration date to enter into a possible transaction with Oncotelic was extended to June 30, 2025.
  • As of December 31, 2024, the Company has accrued $ 740 in interest that is included in other accrued expenses within the accompanying consolidated balance sheet.
  • Critical Accounting Policies and Estimates Our consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America, which require us to make estimates and judgments that significantly affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities.
  • Actual results could differ from those estimates, and such differences could affect the results of operations reported in future periods.
  • We believe the following critical accounting policies affect our most significant estimates and judgments used in the preparation of our consolidated financial statements. 1.
  • Convertible Notes The Company follows Financial Accounting Standards Board (“FASB’s”) Accounting Standards Codification (“ASC”) 480-10, “Distinguishing Liabilities from Equity” in its evaluation of the accounting for share-settled debt (Convertible Notes).
  • ASC 480-10-25-14 requires liability accounting for certain financial instruments, including shares that embody an unconditional obligation to transfer a variable number of shares, provided that the monetary value of the obligation is based solely or predominantly on one of the following three characteristics: a) A fixed monetary amount known at inception; b) Variations in something other than the fair value of the issuer’s equity shares; or c) Variations in the fair value of the issuer’s equity shares, but the monetary value to the counterparty moves in the opposite direction as the value of the issuer’s shares.
  • Moreover, equity classification was not an appropriate classification for the convertible notes because the underlying terms of the convertible notes do not expose the investors to risks and rewards similar to those of an owner and, therefore, do not create a shareholder relationship.
  • Pursuant to ASC 835-30, the convertible notes were initially recorded at their amortized cost and are being accreted to their redemption value over the estimated conversion period using the effective interest method. 2.
  • Income Taxes We follow authoritative guidance in accounting for uncertainties in income taxes.
  • This authoritative guidance prescribes a recognition threshold and measurement requirement for the financial statement recognition of a tax position that has been taken or is expected to be taken on a tax return and also provides guidance on derecognition, classification, interest and penalties, accounting in interim periods, disclosure and transition.
  • Under this guidance, we may only recognize tax positions that meet a “more likely than not” threshold.
  • We follow authoritative guidance to evaluate whether a valuation allowance should be established against our deferred tax assets based on the consideration of all available evidence using a “more likely than not” standard.
  • In making such judgments, significant weight is given to evidence that can be objectively verified.
  • We assess our deferred tax assets annually under more likely than not scenarios in which they may be realized through future income.
  • In addition, utilization of our net operating loss carryforwards may be subject to an annual limitation due to ownership change limitations that may have occurred as a result of the Reverse Merger that closed in August 2020, or that could occur in the future, as required by Section 382 of the Internal Revenue Code of 1986, as amended (the “Code”).
  • These ownership changes may limit the amount of the net operating loss carry forwards that can be utilized annually to offset future taxable income and tax, respectively.
  • In general, an “ownership change” as defined by Section 382 of the Code results from a transaction or series of transactions over a three-year period resulting in an ownership change of more than 50 percentage points of the outstanding stock of a Company by certain stockholders.
  • Moreover, since we will need to raise substantial additional funding to finance our operations, we may undergo further ownership changes in the future, which could further limit our ability to use net operating loss carryforwards.

and 456 more.

Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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