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Market ClerkRecap
Sun Oct 25 · markets closed1 signal on Oct 2494 insider buys this week · $48.3MCIRO short report next: Oct 31The week ahead

CEROW

CERO THERAPEUTICS HOLDINGS, INC.
OTC · HEALTH CARE · BIOLOGICAL PRODUCTS, (NO DIAGNOSTIC SUBSTANCES)
No price history available

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How CEROW rewrote its risk factors

10-K ITEM 1A · FY2024 → FY2025
Text kept
84%
of sentences unchanged
Added
121
new sentences
Dropped
86
sentences removed
Length
+1,689
words, now 44,684

New in FY2025

  • We incurred net losses of approximately $19.9 million and $8.3 million for the years ended December 31, 2025 and 2024, respectively.
  • As of December 31, 2025, we had an accumulated deficit of approximately $90.8 million.
  • Nasdaq has delisted our securities from trading on Nasdaq, which could limit investors’ ability to make transactions in our securities and subject us to additional trading restrictions.
  • On October 29, 2025, we received the determination of the October 2025 Panel to deny our request to continue the listing of our shares of Common Stock on Nasdaq and that the trading in our securities would be suspended at the open of trading on October 31, 2025.
  • The Company’s shares of Common Stock commenced trading on OTCQB as of December 2, 2025.
  • On January 29, 2026, after considering the written record in this matter, the Nasdaq Listing and Hearing Review Council issued its decision affirming the Panel’s decision to delist the Company’s securities from Nasdaq.
  • The OTC Markets are a less liquid market than Nasdaq, which may have a material adverse effect on the trading price and volume for the Common Stock.
  • We are also considering listing alternatives, including applying to list our shares of Common Stock on another securities exchange.
  • The delisting of our securities by Nasdaq has adversely affected and is expected to continue to adversely affect the trading market for our securities, as price quotations are not as readily obtainable, which has had and is expected to continue to have a material adverse effect on the market price of our securities and the Company’s ability to raise additional capital.
  • Moreover, we can provide no assurance that trading in our securities will continue over the counter or otherwise.
  • As a result of the delisting, we could face significant material adverse consequences, including: ● a limited availability of market quotations for our securities; ● reduced liquidity with respect to our securities; ● a determination that our shares of Common Stock are “penny stock”, which will require brokers trading in our shares of Common Stock to adhere to more stringent rules, possibly resulting in a reduced level of trading activity in the secondary trading market for our shares of Common Stock; ● a limited amount of news and analyst coverage for our company; and ● a decreased ability to issue additional securities or obtain additional financing, including pursuant to the Fifth Securities Purchase Agreement, the July 2025 Keystone Purchase Agreement, or otherwise, in the future.
  • The National Securities Markets Improvement Act of 1996, which is a federal statute, prevents or preempts the states from regulating the sale of certain securities, which are referred to as “covered securities.” Because they have been delisted, our securities would not be covered securities and we would be subject to regulation in each state in which we offer our securities.
  • This state level regulation introduces additional compliance requirements for brokers to consider making markets in our securities and will further negatively impact any trading liquidity in our securities.
  • As of December 31, 2025, the Company reported $1.7 million of cash and cash equivalents, with an accumulated deficit of $90.8 million.
  • In its report on our financial statements for the year ended December 31, 2025, our independent registered public accounting firm included an explanatory paragraph that expressed substantial doubt about our ability to continue as a going concern.
  • We have initiated a clinical trial for our first product candidate, CER-1236, in AML, are expanding to MDS and MF patients in the first half of 2026 with later plans to expand into ovarian cancer and NSCLC, and the rest of our product candidates are in the preclinical stages of development.
  • Many of the factors listed above are beyond our control and could cause us to experience significant delays or prevent us from obtaining regulatory approvals or commercializing our product candidates.
  • Advancing these novel product candidates creates significant challenges for us, including: ● manufacturing our product candidates to our regulatory specifications and in a timely manner to support our clinical trials, and, if approved, commercialization; ● sourcing clinical and, if approved, commercial supplies for the raw materials used to manufacture our product candidates; ● understanding and addressing variability in the quality of a donor’s T cells, which could ultimately affect our ability to produce product in a reliable and consistent manner and treat certain patients; ● educating medical personnel regarding the potential side effect profile of our product candidates, if approved, such as the potential adverse side effects related to cytokine release syndrome (“CRS”), neurotoxicity, prolonged cytopenia, coagulation abnormalities, thrombosis, hypotension, aplastic anemia and neutropenic sepsis; ● using medicines to preempt or manage adverse side effects of our product candidates and such medicines may be difficult to source or costly or may not adequately control the side effects or may have other safety risks or a detrimental impact on the efficacy of the treatment; ● conditioning patients with cyclophosphamide and fludarabine in advance of administering our product candidates, which may be difficult to source, costly or increase the risk of infections and other adverse side effects; ● obtaining regulatory approval, as the FDA and other regulatory authorities have limited experience with development of CER T cell therapies for cancer; ● establishing sales and marketing capabilities upon obtaining any regulatory approval to gain market acceptance of a novel therapy; and ● obtaining acceptance and approval by physicians, patients, hospitals, cancer treatment centers and others in the medical community.
  • Although we have initiated our clinical trial for CER-1236 in AML, are expanding to MDS and MF patients in the first half of 2026 with later plans to expand into ovarian cancer and NSCLC, there is no guarantee that we will be able to proceed with clinical development of CER-1236 or any of our other product candidates as planned or that any product candidate will demonstrate a clinical benefit once advanced to testing in patients.
  • Data from our preclinical studies and clinical trials is limited and may change as additional patient data become available or may not be validated in any future or advanced clinical trial.
  • Additionally, manufacturing can impact clinical outcomes.
  • We have submitted INDs to the FDA, and the FDA has cleared us to begin clinical trials for the treatment of AML, MDS and MF as well as the treatment of advanced solid tumors, specifically NSCLC and ovarian cancer, but there are no assurances regarding the acceptance of any amendments or future INDs, which may impact the timelines we expect.
  • For example, our clinical trial for CER-1236 is enrolling patients with hematologic malignancies and dysplasias, including AML, MDS, and MF.
  • We are focused initially on the development of treatments for cancers such as AML, and plan to eventually extend our treatments to other forms of cancer.
  • As of December 31, 2025 and 2024, we had approximately $1.7 million and $3.3 million in cash and cash equivalents, respectively.
  • As of April 14, 2026, the Company currently has outstanding: (i) 36,786,686 shares of Common Stock, (ii) 1,429 shares of Series A Preferred Stock with a stated value of approximately $1.4 million, convertible into shares of Common Stock at a conversion rate of the stated value thereof divided by a current effective conversion price of $0.05 per share; (iii) no shares of Series B Preferred Stock; (iv) 7 shares of Series C Preferred Stock with a stated value of $7,000, convertible into shares of Common Stock at a conversion rate of the stated value thereof divided by a conversion price of $0.05 per share; (v) Series A Warrants to purchase 306 shares of Common Stock at an exercise price of $2,780.00 per share; (vi) Series C Warrants to purchase 4,088 shares of Common Stock at an exercise price of $0.80 per share; (vii) December 2024 and January 2025 Common Warrants to purchase an aggregate of 12,396 shares of Common Stock at an exercise price ranging from $112.20 to $116.40 per share, (viii) February 2025 Common Warrants to purchase an aggregate of 127,551 shares of Common Stock at an exercise price of $39.20 per share, (ix) February 2025 Pre-Funded Warrants to purchase an aggregate of 10,787 shares of Common Stock at an exercise price of $0.002 per share, (x) Public Warrants and Private Placement Warrants to purchase an aggregate of 4,596 shares of Common Stock at an exercise price of $23,000.00 per share, (xi) 5,233 shares of Series D Preferred Stock with a stated value of approximately $5.2 million, convertible into shares of Common Stock at a conversion rate of the stated value thereof divided by a current effective conversion price of $0.05 per share, (xii) 3,816 shares of Series E Preferred Stock with a stated value of approximately $3.8 million, convertible into shares of Common Stock at a conversion rate of the stated value thereof divided by a current effective conversion price of $4.1625 per share and (xii) 50,000,000 shares of Common Stock issuable upon the conversion of the Convertible Notes issued to Keystone.
  • Although each of the conversion price of most of the Preferred Shares and the exercise prices of the December 2024 Common Warrants, January 2025 Common Warrants, Series A Warrants, Public and Private Placement Warrants, and February 2025 Common Warrants are at or above the trading price of our Common Stock as of the date of this Annual Report, if such trading price increases, such conversion prices and exercise prices will not change as a result thereof and could be below the trading price of our Common Stock as of the date of any future conversion or exercise thereof, resulting in dilution to our stockholders.
  • In addition, the terms of the Series A Preferred Stock, the Series C Preferred Stock, the Series D Preferred Stock and the Series E Preferred Stock contain certain penalties and adjustments to the amount included in determination of the conversion rate following certain breaches of the Company’s obligations thereunder, including, among other things, as a result of a failure to file or cause the SEC to declare one or more registration statements relating to the resale of the shares of Common Stock issuable upon conversion thereof by specified deadlines, certain defaults under indebtedness of the Company or judgments against the Company and failure to deliver shares of Common Stock upon conversion in a timely manner.
  • For example, the penalties and adjustments include a 25% premium added to the stated value for determining the conversion rate in connection with breaches other than the breach of the requirement to redeem the shares of Series A Preferred Stock by August 31, 2025, which resulted in a 50% premium, and the addition to the stated value of an amount equal to the value of the shares of Common Stock into which the Series A Preferred Stock would have been convertible if the conversion price were equal to 80% of the lowest volume weighted average price during the five trading days immediately prior to conversion.
  • Such penalties and adjustments, which applied during the period when substantially all of the conversions since the Business Combination occurred as a result of a failure to file and cause the SEC to declare a registration statement with respect to the resale of the underlying shares in a timely manner, have resulted and may in the future result in the issuance of shares of Common Stock at an effective conversion price below the trading price of our Common Stock at the time of such conversion.
  • We cannot assure you that we will remain in compliance with all of the terms of the Series A Preferred Stock, Series C Preferred Stock, Series D Preferred Stock or Series E Preferred Stock and that such penalties and adjustments will not apply in the future.
  • In addition, government funding of the SEC and other government agencies on which our operations may rely, including those that fund R&D activities is subject to the political process, which is inherently fluid and unpredictable, and any reduction in the size of the federal workforce, including through layoffs and severance packages offered to employees, may result in longer review times, including by the FDA or SEC.
  • For example, in 2025, changes and cuts in FDA staffing have been reported as resulting in delays in the FDA’s responsiveness or in its ability to review IND submissions or marketing applications.
  • Over the last several years, including for a 43-day period that began on October 1, 2025, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical FDA, SEC and other government employees and stop critical activities.
  • In addition, we utilize a lymphodepletion regimen, which generally includes fludarabine and cyclophosphamide, that may cause serious adverse events.
  • We have received fast track designation for CER-1236 for AML, and we may seek fast track designation for additional indications, or fast track designation, breakthrough therapy designation, regenerative medicine advanced therapy designation or priority review for one or more of our product candidates, but we might not receive such designation or priority review, and even for those that we do, such designation or priority review may not lead to a faster development or regulatory review or approval process, and does not assure FDA approval of our product candidates.
  • We have received fast track designation for CER-1236 for AML, and we will seek fast track designation for CER-1236 for additional indications.
  • We may further seek fast track, breakthrough therapy, and/or regenerative medicine advanced therapy designations or priority review for one or more of our product candidates.
  • The FDA can accelerate review and approval of products designated as regenerative medicine advanced therapies.
  • A product is eligible for this designation if it is a regenerative medicine therapy that is intended to treat, modify, reverse or cure a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the product has the potential to address unmet medical needs for such disease or condition.

and 81 more.

Gone since FY2024

  • We incurred net losses of approximately $8.3 million and $7.3 million for the years ended December 31, 2024 and 2023, respectively.
  • As of December 31, 2024, we had an accumulated deficit of approximately $70.9 million.
  • As of December 31, 2024, the Company reported $3.3 million of cash and cash equivalents, with an accumulated deficit of $70.9 million.
  • In its report on our financial statements for the year ended December 31, 2024, our independent registered public accounting firm included an explanatory paragraph that expressed substantial doubt about our ability to continue as a going concern.
  • We received clearance of our IND for our first product candidate, CER-1236, and the rest of our product candidates are in the preclinical stages of development.
  • Many of the factors listed above are beyond our control and could cause us to experience significant delays or prevent us from obtaining regulatory approvals or commercialize our product candidates.
  • Advancing these novel product candidates creates significant challenges for us, including: ● manufacturing our product candidates to our regulatory specifications and in a timely manner to support our clinical trials, and, if approved, commercialization; ● sourcing clinical and, if approved, commercial supplies for the raw materials used to manufacture our product candidates; ● understanding and addressing variability in the quality of a donor’s T cells, which could ultimately affect our ability to produce product in a reliable and consistent manner and treat certain patients; ● educating medical personnel regarding the potential side effect profile of our product candidates, if approved, such as the potential adverse side effects related to CRS, neurotoxicity, prolonged cytopenia, coagulation abnormalities, thrombosis, hypotension, aplastic anemia and neutropenic sepsis; ● using medicines to preempt or manage adverse side effects of our product candidates and such medicines may be difficult to source or costly or may not adequately control the side effects or may have other safety risks or a detrimental impact on the efficacy of the treatment; ● conditioning patients with cyclophosphamide, fludarabine, or bendamustine in advance of administering our product candidates, which may be difficult to source, costly or increase the risk of infections and other adverse side effects; ● obtaining regulatory approval, as the FDA and other regulatory authorities have limited experience with development of CER T cell therapies for cancer; ● establishing sales and marketing capabilities upon obtaining any regulatory approval to gain market acceptance of a novel therapy; and ● obtaining acceptance and approval by physicians, patients, hospitals, cancer treatment centers and others in the medical community.
  • Although we received IND clearance for CER-1236 from the FDA in November 2024 and for additional indications in March 2025, and we anticipate beginning clinical trials in the first half of 2025, there is no guarantee that we will be able to proceed with clinical development of CER-1236 or any of our other product candidates or that any product candidate will demonstrate a clinical benefit once we advance these candidates to testing in patients.
  • Data from our preclinical studies is limited and may change as patient data become available or may not be validated in any future or advanced clinical trial.
  • Additionally, manufacturing can impact clinical outcomes and we have not yet completed manufacturing runs with a CDMO.
  • We may also fail to develop and transfer to a CDMO any optimized manufacturing processes for any of our programs.
  • The IND for CER-1236 was filed on June 28, 2024 and on November 15, 2024, the FDA cleared us to begin clinical trials for the treatment of AML and we submitted a second IND application for the investigation of CER-T cell therapy in NSCLC and ovarian cancer, which was accepted by the FDA on March 27, 2025, but there are no assurances regarding the acceptance of any amendments or future INDs, which may impact the timelines we expect.
  • For example, our clinical trial for CER-1236 will seek to enroll patients with hematologic malignancies, including AML, MCL, CLL, and other B cell and myeloid neoplasms.
  • We are focused initially on the development of treatments for cancers such as AML, MCL and CLL, and plan to eventually extend our treatments to other forms of cancer.
  • As of December 31, 2024, we had approximately $3.3 million in cash and cash equivalents.
  • As of April 11, 2025, the Company currently has outstanding (i) 1,429 shares of Series A Preferred Stock with a conversion value of approximately $1.4 million, convertible into shares of Common Stock at a conversion rate of the stated value thereof divided by a current effective conversion price of $1.96; (ii) 198 shares of Series B Preferred Stock with a conversion value of approximately $0.2 million, convertible into shares of Common Stock at a conversion rate of the stated value thereof divided by a floating conversion price of 80% of the lowest volume weighted average price during the five trading days immediately prior to conversion; (iii) 2,537 shares of Series C Preferred Stock with a stated value of approximately $2.5 million, convertible into shares of Common Stock at a conversion rate of the stated value thereof divided by a conversion price of $1.96 (iv) Series A Warrants to purchase 6,127 shares of Common Stock at an exercise price of $139.00 per share; (v) Series C Warrants to purchase 81,753 shares of Common Stock at an exercise price of $0.04; (vi) December 2024 and January 2025 Common Warrants to purchase an aggregate of 247,914 shares of Common Stock at an exercise price ranging from $5.61 to $5.82, (vii) February 2025 Common Warrants to purchase an aggregate of 2,551,020 shares of Common Stock at an exercise price of $1.96, (viii) Pre-Funded Warrants to purchase an aggregate of 215,740 shares of Common Stock at an exercise price of $0.0001, and (ix) Public Warrants and Private Placement Warrants to purchase an aggregate of 91,925 shares of Common Stock at an exercise price of $1,150.00 per share.
  • Although each of the conversion price of the Preferred Shares and the exercise prices of the December 2024 Common Warrants, January 2025 Common Warrants, and Series A Warrants are at or above the trading price of our Common Stock as of the date of this Annual Report, if such trading price increases, such conversion prices and exercise prices will not change as a result thereof and could be below the trading price of our Common Stock as of the date of any future conversion or exercise thereof, resulting in dilution to our stockholders.
  • In addition, the terms of the Series A Preferred Stock, the Series B Preferred Stock and the Series C Preferred Stock contain certain penalties and adjustments to the amount included in determination of the conversion rate following certain breaches of the Company’s obligations thereunder, including, among other things, as a result of a failure to file or cause the SEC to declare one or more registration statements relating to the resale of the shares of Common Stock issuable upon conversion thereof by specified deadlines, certain defaults under indebtedness of the Company or judgments against the Company and failure to deliver shares of Common Stock upon conversion in a timely manner.
  • For example, the penalties and adjustments include a 25% premium added to the stated value for determining the conversion rate in connection with breaches other than the breach of the requirement to redeem the shares of Series A Preferred Stock and Series B Preferred Stock by August 14, 2025, which results in a 50% premium, and the addition to the stated value of an amount equal to the value of the shares of Common Stock into which the Series A Preferred Stock or Series B Preferred Stock would have been convertible if the conversion price were equal to 80% of the lowest volume weighted average price during the five trading days immediately prior to conversion.
  • Such penalties and adjustments, which applied during the period when substantially all of the conversions since the Business Combination described in the preceding paragraph occurred as a result of a failure to file and cause the SEC to declare a registration statement with respect to the resale of the underlying shares in a timely manner, have resulted and may in the future result in the issuance of shares of Common Stock at an effective conversion price below the trading price of our Common Stock at the time of such conversion.
  • We cannot assure you that we will remain in compliance with all of the terms of the Series A Preferred Stock, Series B Preferred Stock or Series C Preferred Stock and that such penalties and adjustments will not apply in the future.
  • In addition, government funding of the SEC and other government agencies on which our operations may rely, including those that fund R&D activities is subject to the political process, which is inherently fluid and unpredictable.
  • The Trump Administration has issued executive orders seeking to greatly reduce the size of the federal workforce, including through layoffs and severance packages offered to employees of federal agencies within the executive branch and independent agencies, including the SEC and the FDA.
  • Any such reduction in personnel may result in longer review times by the FDA or SEC.
  • Over the last several years the U.S. government has shut down several times and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical FDA, SEC and other government employees and stop critical activities.
  • Since March 2020, when foreign and domestic inspections of facilities were largely placed on hold, the FDA has been working to resume pre-pandemic levels of inspection activities, including routine surveillance, bioresearch monitoring and pre-approval inspections.
  • Should the FDA determine that an inspection is necessary for approval and an inspection cannot be completed during the review cycle due to restrictions on travel or otherwise, and the FDA does not determine a remote interactive evaluation to be adequate, the FDA has stated that it generally intends to issue, depending on the circumstances, a complete response letter or defer action on the application until an inspection can be completed.
  • In addition, we utilize a lymphodepletion regimen, which generally includes fludarabine, cyclophosphamide or bendamustine, that may cause serious adverse events.
  • We may seek fast track and breakthrough therapy designations or priority review for one or more of our product candidates, but we might not receive such designation or priority review, and even if we do, such designation or priority review may not lead to a faster development or regulatory review or approval process, and does not assure FDA approval of our product candidates.
  • We may seek fast track, breakthrough therapy, and/or regenerative medicine advanced therapy designations or priority review for one or more of our product candidates.
  • Fast track designation, priority review, and breakthrough therapy designation are within the discretion of the FDA.
  • We may not be able to obtain orphan drug exclusivity for one or more of our product candidates, and even if we do, that exclusivity may not prevent the FDA from approving other competing products.
  • Obtaining orphan drug exclusivity for our product candidates may be important to our commercial strategy.
  • In the United States, federal, state, and local governments have enacted numerous data privacy and security laws, including data breach notification laws, personal data privacy laws, consumer protection laws and other similar laws (e.g., unfair or deceptive acts or practices pursuant to Section 5(a) of the Federal Trade Commission Act).
  • In addition, the California Consumer Privacy Act (“CCPA”), as amended by the California Privacy Rights Act, applies to personal information of consumers, business representatives, and employees, and creates individual privacy rights and places increased privacy and security obligations on entities handling personal data of consumers or households.
  • In addition, several other states have also passed comprehensive privacy laws, and similar laws are being considered in additional states, as well as at the federal and local levels.
  • Moreover, some states, such as Washington, Nevada and Connecticut, adopted legislation protecting consumer health information specifically.
  • Washington’s My Health My Data Act, which is now in effect, features a private right of action, heightening noncompliance risks.
  • Regulators and legislators in the U.S. are increasingly scrutinizing and restricting certain personal data transfers and transactions involving foreign countries.
  • For example, Executive Order 14117 of February 28, 2024, Preventing Access to Americans’ Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern, as implemented by U.S.

and 46 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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