Item 7. Management’s Discussion and Analysis
of Financial Condition and Results of Operations of CERo.
The following discussion
and analysis of CERo’s financial condition and results of operations should be read in conjunction with our audited consolidated
financial statements and the notes related thereto which are included in Item 8 of this Annual Report. Certain information contained in
the discussion and analysis set forth below includes forward-looking statements. Our actual results may differ materially from those anticipated
in these forward-looking statements as a result of many factors, including those set forth under “Cautionary Note Regarding Forward-Looking
Statements,” “Risk Factors” and elsewhere in this Annual Report.
Overview
CERo Therapeutics, Inc. (the
“Predecessor”) was incorporated in Delaware on September 23, 2016, and is based in South San Francisco, California. Predecessor
was focused on developing its therapeutic platform to genetically engineer human immune cells to fight cancer and did not begin clinical
development or product commercialization. The Company’s efforts will focus on continued product development, including clinical
development, to support regulatory approval to commercialize and subsequent product commercialization.
On June 4, 2023, Predecessor
entered into a Business Combination Agreement (as amended by that certain Amendment No. 1 to the Business Combination Agreement, dated
as of February 5, 2024 and Amendment No. 2 to the Business Combination Agreement, dated as of February 13, 2024, the “Business Combination
Agreement”) by and among PBAX and PBCE Merger Sub, Inc., pursuant to which Merger Sub merged with and into Predecessor, with Predecessor
surviving as a wholly-owned subsidiary of PBAX (the “Merger”). In connection with the consummation of the Business Combination
on February 14, 2024, PBAX changed its corporate name to “CERo Therapeutics Holdings, Inc.”
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At the effective time of
the Merger, (i) each outstanding share of Predecessor common stock, was cancelled and converted into the right to receive shares of Common
Stock; (ii) each outstanding option to purchase Predecessor common stock was converted into an option to purchase shares of Common Stock,
par value $0.0001 per share; (iii) each outstanding share of Predecessor preferred stock, was converted into the right to receive shares
of Common Stock, and (iv) each outstanding warrant to purchase Predecessor preferred stock was converted into a warrant to acquire shares
of Common Stock. In addition, each outstanding Predecessor convertible bridge note was exchanged for shares of Series A Preferred Stock.
In addition, the holders
of Predecessor common stock and Predecessor preferred stock have the contingent right to receive the Earnout Shares. At the Closing, the
Company issued three pools of shares of Common Stock subject to forfeiture if the applicable conditions to transferability thereof are
not satisfied: (i) 12,000 shares of Common Stock (giving retroactive effect to the Reverse Stock Split), which will be fully vested upon
the achievement of certain adjusted stock price-based earnout targets or upon a qualifying transaction (ii) 8,750 shares of Common Stock
(giving retroactive effect to the Reverse Stock Split), pursuant to a Letter Agreement, dated as of February 14, 2024 which were fully
vested at Closing of the Merger and which were issued as an offset to the Sponsor Share Forfeiture Agreement, and (iii) 10,000 shares
of Common Stock (giving retroactive effect to the Reverse Stock Split), which were fully vested upon the June 28, 2024 achievement of
certain regulatory milestone-based earnout targets.
As consideration for the
Merger, the Company issued to Predecessor stockholders an aggregate of 84,483 shares of Common Stock, including 22,000 Earnout Shares
and 3,733 shares issuable upon exercise of rollover options or warrants (giving retroactive effect to the Reverse Stock Split).
Going concern
The accompanying financial
statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets
and satisfaction of liabilities in the normal course of business. The Company’s ability to continue as a going concern is dependent
on its ability to raise additional capital to fund its R&D activities and meet its obligations on a timely basis. As of December 31,
2024, the Company reported $3.3 million of cash and cash equivalents, with an accumulated deficit of $70.9 million. On February 5, 2025,
the Company entered into a securities purchase agreement (the “SPA”), with participation from a member of the Board and a
single institutional investor, for the purchase and sale of (i) 2,551,020 shares of Common Stock or Common Stock equivalents in lieu thereof;
and (ii) February 2025 Common Warrants to purchase up to 2,551,020 shares of Common Stock at an exercise price of $1.96. In connection
with such offering, the Company received net proceeds of approximately $4.5 million. Additionally, since December 31, 2024, the Company
received net proceeds from the exercise of the remaining Series A Warrants, the collection of subscriptions receivable and equity line
of credit fundings of approximately $2.5 million. Additional funds are necessary to maintain current operations and to continue R&D
activities. However, there can be no assurance that sufficient funding will be available to allow the Company to successfully continue
its R&D activities and planned regulatory filings with the FDA. If the Company is unable to obtain the necessary funds, significant
reductions in spending and the delay or cancellation of planned activities may be necessary. These actions would have a material adverse
effect on the Company’s business, results of operations, and prospects. These conditions raise substantial doubt about the Company’s
ability to continue as a going concern within one year from the date these accompanying financial statements are issued. The accompanying
financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the
amounts and classification of liabilities that might result from the outcome of this uncertainty.
Recent Developments
Reverse Stock Split
At 12:01 a.m. Eastern time
on January 8, 2025, we effected the Reverse Stock Split pursuant to which each 100 shares of our Common Stock outstanding immediately
prior thereto was converted into 1 share of our Common Stock outstanding immediately thereafter.
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February 2025 Offering
On February 7, 2025, we closed
our reasonable best efforts public offering, with participation from a member of our board of directors and a single institutional investor,
for the purchase and sale of (i) 2,551,020 shares of Common Stock or common stock equivalents in lieu thereof; and (ii) February 2025
Common Warrants to purchase up to 2,551,020 shares of common stock, at a combined public offering price of $1.96 per share and warrant.
In connection with the offering, on February 5, 2025, we entered into the SPA with the investors. Such transaction is referred to as the
“February 2025 Offering.” The shares of Common Stock and the Warrants described above and the shares of Common Stock underlying
the Warrants were offered pursuant to the Registration Statement on Form S-1 (File No. 333-284007), as amended, which was declared effective
by the Securities and Exchange Commission on February 5, 2025. In connection with this offering, we received net proceeds of approximately
$4.5 million.
Investigational New Drug
Application Submission
On June 28, 2024, the Company
submitted an Investigational New Drug Application (“IND”) for its product candidate, CER-1236, to FDA. On July 26, 2024, the
Company was informed by the FDA that it has placed a clinical hold on the IND. The FDA indicated that the clinical hold has been placed
as a result of insufficient data provided with regard to two issues within pharmacology and toxicology of CER-1236. The FDA indicated
that, within 30 calendar days, it would provide a detailed official hold letter and requested that the Company hold its response until
after receipt of such letter (the “Hold Letter”).
The Company received the
Hold Letter on July 26, 2024 and submitted a complete response letter to the FDA on October 21, 2024 in which the Company requested a
meeting to address the FDA’s questions.
On November 15, 2024, the Company received notice from the FDA that
the IND for CER-1236 was cleared. The Company currently anticipates beginning clinical trials in the first half of 2025. 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.
Nasdaq Notices of Non-compliance
and Nasdaq Panel Decision
On July 19, 2024, the Company
received a letter (the “Bid Price Requirement Letter”) from the staff at The Nasdaq Global Market notifying the Company that,
for the 30 consecutive trading days prior to the date of the Bid Price Requirement Letter, the closing bid price for the Common Stock
had not been in compliance with the Bid Price Requirement. On October 23, 2024, the trading price for CERo common stock closed under $0.10
and was the tenth consecutive trading day to do so. On October 24, 2024, the Company received a letter from the staff at The Nasdaq Global
Market notifying the Company that, because its Common Stock had a closing bid price of $0.10 or less for ten consecutive trading days,
it was no longer eligible to rely upon the 180-day cure period set forth in the Bid Price Requirement Letter.
On July 19, 2024, the Company
also received the MVPHS Letter notifying the Company that, for the 30 consecutive trading days prior to the date of the MVPHS Letter,
the Common Stock had not been in compliance with the MVPHS Requirement.
Such letters are in addition
to the letter from The Nasdaq Global Market received by the Company on May 2, 2024 (the “MVLS Letter” and, together with the
Bid Price Requirement Letter and the MVPHS Letter, the “Letters”) notifying the Company that, for the 30 consecutive trading
days prior to the date of such MVLS Letter, the Common Stock had traded at a value below the minimum $50,000,000 “Market Value of
Listed Securities” (“MVLS”) requirement set forth in Nasdaq Listing Rule 5450(b)(2)(A), which is required for continued
listing of the Common Stock on The Nasdaq Global Market (the “MVLS Requirement”). On October 30, 2024, the Company received
a letter from the staff at The Nasdaq Global Market notifying the Company that it had not regained compliance with the MVLS Requirement
within the 180-day compliance period set forth in the MVLS Letter.
Each of the Bid Price Requirement
and MVLS Requirement deficiencies results in the commencement of delisting proceedings. However, the Company attended a hearing before
the Nasdaq Panel on December 17, 2024, at which the Company submitted a plan for regaining compliance. Notwithstanding that applicable
Nasdaq rules provide a 180-day compliance period to regain compliance with the MVPHS Requirement, the plan submitted by the Company in
connection with such hearing, as required by applicable Nasdaq requirements, demonstrated a pathway to compliance with all applicable
deficiencies.
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On January 17, 2025, the
Nasdaq Panel granted the Company’s request for an extension of the deadline for regaining compliance with Nasdaq listing requirements
to April 22, 2025, subject to Nasdaq Conditions. Pursuant to the Nasdaq Conditions, the Company shall demonstrate compliance with the
Bid Price Requirement and apply to transfer its listing to the Nasdaq Capital Market on or prior to January 22, 2025. The Company is also
required to satisfy the $2.5 million stockholders’ equity requirement of the Nasdaq Capital Market on or prior to April 22, 2025,
submit certain plans to Nasdaq and make certain disclosures.
On February 12, 2025, we
received a letter from Nasdaq confirming that we have regained compliance with the Bid Price Requirement and we have been moved to the
Nasdaq Capital Market, as required by the Nasdaq Panel.
Regaining compliance with the Bid Price Requirement is one of the conditions
set forth by the Nasdaq Panel in its previously disclosed decision granting our request for an extension to regain compliance with certain
Nasdaq continued listing requirements until April 22, 2025. We continue to make progress towards satisfaction of the other conditions.
Nevertheless, as of the date of this Annual Report, the trading price of our Common Stock is below the Bid Price Requirement and we have
not satisfied the $2.5 million stockholder’s equity requirement. We cannot assure you that we will obtain compliance with these
requirements in a timely manner, or at all.
Warrant Issuances
On December 23, 2024, the Company issued warrants to purchase an aggregate
of 84,061 shares of Common Stock, with an exercise price of $5.61 per share, which was the closing price of the Common Stock on Nasdaq
on December 20, 2024, to certain institutional investors as a condition to the exercise of Preferred Warrants held thereby. On January
6, 2025, the Company issued additional warrants to purchase an aggregate of 163,853 shares of Common Stock, with an exercise price of
$5.82 per share, which was the closing price of the Common Stock on Nasdaq on January 3, 2025, to an institutional investor as a condition
to the exercise of Preferred Warrants held thereby. Such number of shares gives effect to the Reverse Stock Split.
Results of Operations
Revenue
Predecessor and the Company
have not recognized any revenue from any sources, including from product sales, and the Company does not expect to generate any revenue
from the sale of products in the foreseeable future. If the development efforts for the Company’s product candidates, each of which
is a specific product and indication combination, are successful and result in regulatory approval, or if the Company executes license
agreements with third parties, the Company may generate revenue from R&D services, from the achievement of development milestones
or from milestones and royalties related to product sales. However, there can be no assurance as to when any revenues will be generated,
if at all.
Operating Expenses
Research and Development Expenses
R&D expenses consist
of discovery activities, manufacturing development and production, preclinical and clinical development, and regulatory filing for product
candidates. R&D expenses are recognized as incurred and payments made prior to the receipt of goods or services to be used in R&D
are capitalized until the goods or services are received. Costs incurred in obtaining technology licenses through asset acquisitions,
if incurred, will be charged to R&D expense if the licensed technology has not reached technological feasibility and has no alternative
future use. R&D expenses include or could include:
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● product-liability insurance for clinical development product(s);
● laboratory supplies and research materials;
● software and systems related to R&D activities;
● costs related to regulatory filing and compliance; and
Product candidates in later
stages of development generally have higher development costs than those in earlier stages of clinical development, primarily due to the
increased size and duration of later-stage clinical trials. The Company plans to substantially increase its R&D expenses for the foreseeable
future as it continues the development of its product candidates through clinical development. The Company cannot determine with certainty
the timing of initiation, the duration or the costs of current or future preclinical studies and clinical trials required for regulatory
approval due to the inherently unpredictable nature of preclinical and clinical development. Clinical and preclinical development timelines,
the probability of success and development costs can differ materially from expectations. The Company anticipates that it will make determinations
as to which product candidates to pursue and how much funding to direct to each product candidate on an ongoing basis in response to the
results of ongoing and future preclinical studies and clinical trials, regulatory developments and ongoing assessments as to each product
candidate’s commercial potential. The Company will need to, and plans to, raise substantial additional capital in the future. Future
R&D expenses may vary significantly between periods and from current expectations based on factors such as:
● potential additional safety monitoring requested by regulatory agencies;
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General and Administrative Expenses
General and administrative
expenses consist principally of salaries and related costs for personnel in executive and administrative functions, including stock-based
compensation, travel expenses and recruiting expenses. Other general and administrative expenses include professional fees for legal,
accounting and tax-related services, consulting fees, insurance costs, and investor relations fees.
The Company anticipates that
its general and administrative expenses will increase in the future as the Company increases headcount and contracted services for operational
support for expanded operations and infrastructure. The Company also anticipates that general and administrative expenses will increase
as a result of expenses for accounting, audit, legal and consulting services, as well as costs associated with maintaining compliance
with Nasdaq listing rules and SEC requirements, director and officer liability insurance, investor and public relations activities and
other expenses associated with operating as a public company.
Other Income, Net
Other income, net consists predominantly of interest income from interest
bearing bank accounts, interest expense on payables, gains recorded on settlements reached with vendors on payables, and the gain or loss
on the revaluation of earnout and derivative liabilities, which represents the change in fair value of earnout liabilities or outstanding
warrants between periods.
Results of Operations for the years ended December
31, 2024 and 2023
The Results of Operations
for year ended December 31, 2024 are pro forma as the period presented in the following table and discussion includes the Predecessor
for the period from January 1, 2024 through February 13, 2024 and the Company for the period from February 14, 2024 through December 31,
2024. This pro forma period from January 1, 2024 to December 31, 2024 does not include the Merger transactions that occurred on-the-line.
For the Years Ended December 31,
Operating expenses:
Other income (expense):
General and Administrative Expenses
General and administrative expenses were $9.1 million for the year
ended December 31, 2024, compared to $2.4 million for the year ended December 31, 2023, reflecting an increase of $6.7 million. The increase
in the year ended December 31, 2024, over the year ended December 31, 2023, was partially due to a $1.8 million expense consisting of
the remaining underwriting fees from the PBAX initial public offering, which were earned on the consummation of the business combination.
Additionally, the hiring of senior management in G&A resulted in an increase of $2.0 million, including recruiting fees. Legal fees
increased $1.0 million and business consulting increased $0.8 million in the year ended December 31, 2024, versus the year ended December
31, 2023. Expenses related to services required for SEC compliance, such as printing and transfer agency fees, increased $0.5 million
and public company insurance coverage increased insurance expenses $0.5 million in the year ended December 31, 2024, compared to the year
ended December 31, 2023. Corporate communications and director fees each increased $0.2 million in the year ended December 31, 2024 compared
to the year ended December 31, 2023. The additional expenses are all driven by the increased expenses of operational compliance as a public
company.
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Research and Development Expenses
Research and development
expenses were $7.6 million for the year ended December 31, 2024, compared to $5.3 million for the year ended December 31, 2023, reflecting
an increase of $1.8 million. The increase was related to increased R&D activity as the Company prepared and filed the IND for CER-1236,
prepared for the clinical trial initiation, and conducted additional experiments in response to the FDA questions related to the IND. Clinical expenses increased $0.2 million, and scientific consulting
expenses increased $1.2 million in the year ended December 31, 2024, due to activities related to the preparation of the IND and responses
to questions from the FDA, and preparation for the anticipated clinical trial for CER-1236. Additional studies required to address FDA
questions increased preclinical study costs by $0.3 million.
The Company anticipates that
its R&D expenses will significantly increase in the future as the Company increases headcount, compensation expense, and contracted
services for preclinical and clinical development of its product candidates, as well as for manufacturing of clinical product to be used
in clinical development.
Other Income, Net
Other income was $7.9 million
for the year ended December 31, 2024, compared to $0.4 million for the year ended December 31, 2023, reflecting an increase of $7.5 million.
The increase in 2024 as compared to 2023 was primarily due to the $4.8 million positive change in value of the Company’s earnout
liability and the $0.4 million gain recorded for the change in value of the Predecessor’s preferred stock warrant liability in the
year ended December 31, 2024. Additionally, settlement of vendor liabilities in 2024 resulted in a $3.3 million increase in other income
in 2024. This other income was offset by an increase in other expenses attributable to an increase in registration and other penalties
of $0.6 million and a decrease in interest income of $0.1 million.
Net loss and net loss attributable to common
stockholders
For the years ended December
31, 2024 and 2023, net loss amounted to $8.3 million and $7.3 million, respectively, an increase of $1.0 million, or 13.9%. During 2024,
in connection with our Series A and Series B preferred stock conversions and the repricing of Series A Warrants, we recorded a deemed
dividend of $2.8 million. Accordingly, for the years ended December 31, 2024 and 2023, net loss attributable to common stockholders amounted
to $11.1 million, or $(19.14) per common share, and $7.3 million, or $(97.90) per common share, respectively.
Liquidity and Capital Resources
Capital Requirements
Predecessor and the Company
have not generated any revenue from any source and the Company does not expect to generate revenue for at least the next few years. If
the Company fails to complete the timely development of, or fails to obtain regulatory approval for, its product candidates, the ability
of the Company to generate future revenue will be adversely affected. The Company does not know when, or if, it will generate any revenue
from its product candidates, and does not expect to generate revenue unless and until the Company obtains regulatory approval and commercialization
of its product candidates.
The Company expects its expenses
to increase significantly in connection with its ongoing activities, particularly as it continues and expands research, preclinical development,
and clinical development to support marketing approval for its product candidates. In addition, if the Company obtains approval for any
of its product candidates, the Company expects to incur significant commercialization expenses related to sales, marketing, manufacturing
and distribution. Furthermore, the Company expects to incur additional costs associated with operating as a public company.
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The Company, therefore, anticipates that substantial additional funding
will be needed in connection with its continuing operations. At December 31, 2024, the Company had $3.3 million in cash and cash
equivalents. The Company intends to devote most of the available cash to the preclinical and clinical development of its product candidates
and public company compliance costs. Based on current business plans, the Company believes that the cash available at December 31, 2024
will not fund its operations and capital requirements for 12 months after the filing of the audited financial statements for the year
ended December 31, 2024. The Company has arranged two equity lines of credit, one providing for the sale of up to 25,000,000 newly issued
shares of Common Stock and the other providing for the purchase of up to $25 million of Common Stock on the satisfaction of certain conditions.
The Company has no guarantee that the conditions will be satisfied to require the purchase of all, or any additional amount, of the ELOC
funds. On February 5, 2025, the Company entered into the SPA, with participation from a member of the Company’s Board and a single
institutional investor, for the purchase and sale of (i) 2,551,020 shares of our common stock or common stock equivalents in lieu thereof;
and (ii) February 2025 Common Warrants to purchase up to 2,551,020 shares of common stock, at a combined public offering price of $1.96
per share and warrant. In connection with this offering, the Company received net proceeds of approximately $4.5 million. Additionally,
since December 31, 2024, the Company received net proceeds from the exercise of the remaining Series A Preferred Warrants, the collection
of subscriptions receivable and ELOC fundings of approximately $2.5 million. Any estimate as to how long the Company expects the net proceeds
from the ELOC funding may fund the Company’s operations is based on assumptions that may prove to be wrong, and the Company could
use its available capital resources sooner than its current expectations. Changing circumstances, some of which may be beyond the Company’s
control, could result in less cash and cash equivalents available to fund operations or cause the Company to consume capital significantly
faster than currently anticipated, and the Company may need to seek additional funds from additional sources sooner than planned.
Because of the numerous risks
and uncertainties associated with research, development and commercialization of pharmaceutical drug products, the Company is unable to
estimate the exact amount of its operating capital requirements. The Company’s future funding requirements will depend on many factors,
including, but not limited to those listed under “Factors Affecting Our Performance” above.
Identifying potential product
candidates and conducting preclinical studies and clinical trials is a time-consuming, expensive and uncertain process that takes many
years to complete, and the Company may never generate the necessary data or results required to obtain marketing approval and achieve
product sales. In addition, the Company’s product candidates, if approved, may not achieve commercial success. Commercial revenues,
if any, will be derived from sales of product candidates that the Company does not expect to be commercially available in the near term,
if at all. Accordingly, the Company will need to continue to rely on additional financing to achieve its business objectives. Adequate
additional financing may not be available to the Company on acceptable terms, or at all. To the extent that the Company raises additional
capital through the sale of equity or convertible debt securities, the terms of these equity securities or this debt may restrict the
Company’s ability to operate. Any future debt financing and equity financing, if available, may involve covenants limiting and restricting
the ability to take specific actions, such as incurring additional debt, making capital expenditures, entering into profit-sharing or
other arrangements or declaring dividends. If the Company raises additional funds through collaborations, strategic alliances or marketing,
distribution or licensing arrangements with third parties, it may be required to relinquish valuable rights to its technologies, future
revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to the Company. If the
Company is unable to raise capital when needed or on acceptable terms, the Company could be forced to delay, reduce or eliminate its R&D
programs or future commercialization efforts.
Cash Flows
For the Years Ended December 31,
(Pro forma, Predecessor and Successor) 2023 (Predecessor) Difference
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Net cash used in operating activities
Net cash used in operating activities for the year ended December 31,
2024 primarily reflected a net loss of $8.3 million, adjusted for the reconciliation of non-cash items such as a gain on of the settlement
of vendor liabilities of $3.3 million, depreciation expense of $0.4 million, stock-based compensation of $0.9 million, amortization of
right-of-use asset of $0.7 million and a gain on revaluation of derivative and earnout liabilities of $5.2 million, and changes in operating
asset and liabilities primarily consisting of an increase in prepaid expenses and other current assets of $0.1 million, an increase in
accounts payable of $0.2 million, an increase in accrued liabilities of $2.3 million, and a decrease in operating lease liabilities of
$0.8 million.
Net cash used in operating activities for the year ended December 31,
2023 primarily reflected a net loss of $7.3 million, adjusted for the reconciliation of non-cash items such as depreciation expense of
$0.5 million, stock-based compensation of $0.1 million, amortization of right-of-use asset of $0.7 million and a gain on revaluation of
the preferred stock warrant liability of $0.3 million, and changes in operating asset and liabilities primarily consisting of an increase
in prepaid expenses and other current assets of $0.1 million, an increase in accounts payable of $1.3 million, and a decrease in operating
lease liabilities of $0.7 million.
Net cash provided by financing activities
Net cash provided by financing
activities for the year ended December 31, 2024 amounted to $13.73 million as compared to $0.6 million for the year ended December 31,
2023.
During the year ended December 31, 2024, net cash provided by financing
activities of $13.7 million was primarily attributable to the receipt of net proceeds of $7.2 million from the issuance of Series A and
B Preferred Stock, net proceeds of $0.8 million from the issuance of Series C Preferred Stock and associated warrants, net proceeds of
$4.8 million for the sale of common stock under the ELOC, and proceeds from the exercise of Series A warrants of $0.9 million.
During the year ended December
31, 2023, net cash provided by financing activities of $0.6 million was primarily attributable to the receipt of net proceeds of $0.6
million from the issuance of convertible notes payable.
Critical Accounting Estimates
Earnout liability- As a result
of the Merger in February 2024, the Company recognized an earnout liability of $4.9 million on the merger date. The earnout liability
is measured using unobservable (Level 3) inputs and was included in current liabilities on balance sheet. The Company estimated
the fair value of the earnout liability by applying a Monte-Carlo simulation method using the Company’s projection of future operating
results and the estimated probability of achievement of the earnout target metrics. The Monte-Carlo simulation is a generally
accepted statistical technique used to generate a defined number of valuation paths in order to develop a reasonable estimate of the
fair value of the earnout liability. The liability is remeasured to fair value using the Monte-Carlo simulation method at each reporting
period, and the change in fair value is recognized in other income (expense) until the contingency is resolved. During the year ended
December 31, 2024, the Company recorded a gain from change of fair value of the earnout liability of $4,880,000, which is included in
other income, net on the accompanying consolidated statement of operations.
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Stock-based compensation –
The Company periodically issues common stock and stock options to officers, directors, and consultants for services rendered. Stock-based
compensation accounting requires the recognition of stock-based compensation expense, using a grant date fair value-based method, for
costs related to all share-based payments including stock options and restricted stock awards granted to employees and non-employees.
Companies are required to estimate the fair value of all share-based payment awards on the date of grant using an option pricing model,
and the Company uses a Black-Scholes option pricing model (“Black-Scholes”) to estimate option award fair value. The assumptions
used in calculating the fair value of stock-based awards represent management’s best estimates and involve inherent uncertainties
and the application of management’s judgment. The fair value of restricted stock awards is based upon the estimated share price
of the common shares on the date of grant. Forfeitures are accounted for as they occur, and the Company applies the simplified method
to estimate expected term of “plain vanilla” options. All options and restricted stock awards granted since inception are
expensed on a straight-line basis over the requisite service period, which is usually the vesting period, or upon the completion of certain
performance-based vesting terms and the related amounts are recognized in the statements of operations.
The accounting for stock
options granted to outside consultants is consistent with the accounting for stock-based payments to officers and directors, as described
above, by measuring the cost of services received in exchange for equity awards utilizing the grant date fair value of the awards, with
the cost recognized as stock-based compensation expense on the straight-line basis in the Company’s financial statements over the
vesting period of the awards.
Recent Accounting Standards
See the section titled in
Note 2 to the Company’s consolidated financial statements for the year ended December 31, 2024, appearing elsewhere herein.
Item 7A. Quantitative and Qualitative Disclosures
About Market Risk.
We are a smaller reporting company as defined by Rule 12b-2 of the
Securities Exchange Act of 1934, as amended (the “Exchange Act”) and are not required to provide the information under this
item.
Item 8. Financial Statements and Supplementary
Data.
Our consolidated financial
statements for the year ended December 31, 2024, together with the reports of our independent registered public accounting firm, appear
beginning on page F-1 of this Annual Report.
Item 9. Changes in and Disagreements with Accountants on Accounting
and Financial Disclosure.
None.
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Item 9A. Controls and Procedures.
(a) Evaluation of Disclosure Controls and Procedures
Disclosure controls are procedures
that are designed with the objective of ensuring that information required to be disclosed in our reports filed under the Exchange Act
is recorded, processed, summarized, and reported within the time period specified in the SEC’s rules and forms. Disclosure controls
are also designed with the objective of ensuring that such information is accumulated and communicated to our management, including the
Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure.
As required by Rules 13a-15 and 15d-15 under the Exchange Act, our
Chief Executive Officer and Chief Financial Officer carried out an evaluation of the effectiveness of the design and operation of our
disclosure controls and procedures as of December 31, 2024. Based upon their evaluation, our Chief Executive Officer and Chief Financial
Officer concluded that, as a result of the material weakness in internal control over financial reporting as described below, our disclosure
controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) were not effective as of December 31, 2024.
(b) Management’s Report on Internal Control
over Financial Reporting
Our management is responsible for establishing and maintaining adequate
internal control over financial reporting, as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act. Our internal
control over financial reporting is designed to provide reasonable assurance regarding the reliability of financial reporting and the
preparation of our consolidated financial statements for external reporting purposes in accordance with the accounting principles generally
accepted in the United States of America (“GAAP”). Our internal control over financial reporting includes those policies and
procedures that:
(1) pertain to the maintenance
of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of our company;
(2) provide reasonable assurance
that transactions are recorded as necessary to permit preparation of consolidated financial statements in accordance with GAAP, and that
our receipts and expenditures are being made only in accordance with authorizations of our management and directors; and
(3) provide reasonable assurance
regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect
on the consolidated financial statements.
Because of its inherent limitations,
internal control over financial reporting may not prevent or detect errors or misstatements in our consolidated financial statements.
Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because
of changes in conditions, or that the degree or compliance with the policies or procedures may deteriorate. Management assessed the effectiveness
of our internal control over financial reporting at December 31, 2024. In making these assessments, management used the criteria set forth
by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control - Integrated Framework (2013). Based on our
assessments and those criteria, management concluded that our internal control over financial reporting was not effective as of December
31, 2024 as a result of the material weakness in internal control over financial reporting as described below.
Our certifying officers concluded that the Company lacks effective
processes and controls to ensure the accuracy and completeness of its financial statements due to the lack of sufficient and qualified
resources. This material weakness led to the Company consistently failing to meet contractual deadlines for filing its financial statements.
In order to remediate the material weakness, the Company plans to hire additional qualified accounting personnel when the Company
has the financial resources to support such expenses, as well as engage consultants and purchase software licenses, if, and to the extent,
that the Company has sufficient financial resources for such additional expenses.
Management continues to evaluate
its plan to remediate the material weakness, which will not be considered remediated until management designs and implements effective
controls that operate for a sufficient period of time and management has concluded, through testing, that these controls are effective.
This Annual Report does not
include an attestation report of our independent registered public accounting firm due to our status as an emerging growth company under
the JOBS Act.
110
(c) Changes in Internal Control over Financial
Reporting
Other than described above, there
were no changes in our internal control over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f) of the Exchange
Act) during the year to which this Report relates that have materially affected or are reasonably likely to materially affect our internal
control over financial reporting.
(d) Inherent Limitations on Effectiveness of Controls
Our disclosure controls and
procedures and internal control over financial reporting are designed to provide reasonable assurance of achieving the desired control
objectives. Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable
assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of
possible controls and procedures. Similarly, an evaluation of controls cannot provide absolute assurance that misstatements due to error
or fraud will not occur or that all control issues and instances of fraud, if any, have been detected.
Item 9B. Other Information.
Rule 10b5-1 Plan or non-Rule
10b5-1 Trading Arrangements
During the three-month period
ended December 31, 2024, none of our directors or officers (as defined in Rule 16a-1(f) of the Securities Exchange Act of 1934, as amended)
adopted, terminated or modified a Rule 10b5-1 trading arrangement or any “non-Rule 10b5-1 trading agreement” (as defined in
Item 408(c) of Regulation S-K).
Item 9C. Disclosure Regarding Foreign Jurisdictions
that Prevent Inspections.
Not applicable.
111
PART III
Item 10. Directors, Executive Officers and
Corporate Governance.
The information required
under this item is incorporated herein by reference to our definitive proxy statement pursuant to Regulation 14A, which proxy statement
will be filed with the SEC not later than 120 days after the close of our fiscal year ended December 31, 2024.
Item 11. Executive Compensation.
The information required
under this item is incorporated herein by reference to our definitive proxy statement pursuant to Regulation 14A, which proxy statement
will be filed with the SEC not later than 120 days after the close of our fiscal year ended December 31, 2024.
Item 12. Security Ownership of Certain Beneficial
Owners and Management Related Stockholder Matters.
The information required
under this item is incorporated herein by reference to our definitive proxy statement pursuant to Regulation 14A, which proxy statement
will be filed with the SEC not later than 120 days after the close of our fiscal year ended December 31, 2024.
Item 13. Certain Relationships and Related
Party Transactions, and Director Independence.
The information required
under this item is incorporated herein by reference to our definitive proxy statement pursuant to Regulation 14A, which proxy statement
will be filed with the SEC not later than 120 days after the close of our fiscal year ended December 31, 2024.
Item 14. Principal Accountant Fees and Services.
The information required
under this item is incorporated herein by reference to our definitive proxy statement pursuant to Regulation 14A, which proxy statement
will be filed with the SEC not later than 120 days after the close of our fiscal year ended December 31, 2024.
112
PART IV
Item 15. Exhibit and Financial Statement Schedules.
(3) Exhibits:
The following list of exhibits
includes exhibits submitted with this Annual Report as filed with the SEC and those incorporated by reference to other filings.
Exhibit No. Description
113
4.5* Description of Securities.
114
115
116
24.1 Power of Attorney (included on signature page).
101.SCH Inline XBRL Taxonomy Extension Schema Document.
101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF Inline XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB Inline XBRL Taxonomy Extension Label Linkbase Document.
101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase Document.
104 Cover Page Interactive Data File (embedded within the Inline XBRL document).
* Filed herewith.
+ Indicates management contract or compensatory plan.
Item 16. Form 10-K Summary.
None.
117
SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this Annual Report on Form 10-K to be signed on its
behalf by the undersigned, thereunto duly authorized.
CERO THERAPEUTICS HOLDINGS, INC.
Date: April 15, 2025 By: /s/ Chris Ehrlich
Chris Ehrlich
Chairman, Chief Executive Officer and Director
(Principal Executive Officer)
Date: April 15, 2025 By: /s/ Andrew Kucharchuk
Andrew Kucharchuk
Chief Financial Officer
(Principal Financial Officer and Principal Accounting Officer)
POWER OF ATTORNEY
KNOW
ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints each of Chris Ehrlich and Andrew
Kucharchuk his or her true and lawful attorney-in-fact and agent, with full power of substitution, for him or her and in his or her name,
place and stead, in any and all capacities, to sign any and all amendments to this Annual Report on Form 10-K, and to file the same, with
all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorney-in-fact
and agent, full power and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith,
as fully to all intents and purposes as he or she might or could do in person, hereby ratifying and confirming all that said attorney-in-fact
and agent, or his or her substitutes or substitute, may lawfully do or cause to be done by virtue hereof.
Pursuant
to the requirements of the Securities Exchange Act of 1934, as amended, this Annual Report on Form 10-K has been signed below by the following
persons on behalf of the Registrant in the capacities and on the dates indicated.
Name Title Date
Chris Ehrlich (Principal Executive Officer)
/s/ Andrew Kucharchuk Chief Financial Officer April 15, 2025
Andrew Kucharchuk (Principal Financial and Accounting Officer)
/s/ Brian Atwood Director April 15, 2025
Brian Atwood
/s/ Michael Byrnes Director April 15, 2025
Michael Byrnes
/s/ Kathleen LaPorte Director April 15, 2025
Kathleen LaPorte
/s/ Shami Patel Director April 15, 2025
Shami Patel
/s/ Lindsey Rolfe Director April 15, 2025
Lindsey Rolfe
118
CERO THERAPEUTICS HOLDINGS, INC.
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2024 and 2023
Report of Independent Registered Public Accounting Firm (PCAOB ID No. 392) F-2
Notes to Consolidated Financial Statements F-7 to F-33
F-1
Report of Independent Registered Public Accounting
Firm
To the Stockholders and the Board of Directors of CERo Therapeutics
Holdings, Inc.:
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of CERo
Therapeutics Holdings, Inc. (the Company) as of December 31, 2024 (Successor) and December 31, 2023 (Predecessor), the related statements
of operations, convertible preferred stock and stockholders’ deficit, and cash flows for the periods from January 1, 2024 through
February 13, 2024 (Predecessor), and February 14, 2024 through December 31, 2024 (Successor) and for the year ended December 31, 2023
(Predecessor), and the related notes to the consolidated financial statements (collectively, the financial statements). In our opinion,
the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024 (Successor)
and December 31, 2023 (Predecessor), and the results of its operations and its cash flows for the periods from January 1, 2024 through
February 13, 2024 (Predecessor), and February 14, 2024 through December 31, 2024 (Successor) and for the year ended December 31, 2023
(Predecessor), in conformity with accounting principles generally accepted in the United States of America.
Emphasis of a Matter Regarding Going Concern
The accompanying financial statements have been prepared assuming that
the Company will continue as a going concern. As discussed in Note 1 to the financial statements, the Company has incurred net losses
since its inception, has negative cash flows from operations and will need additional funding to complete planned development efforts.
This raises substantial doubt about the Company’s ability to continue as a going concern. Management’s plans in regard to
these matters also are described in Note 1. The financial statements do not include any adjustments that might result from the outcome
of this uncertainty.
Basis for Opinion
These financial statements are the responsibility of the Company’s
management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public
accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent
with respect to the Company in accordance with U.S. federal securities laws and the applicable rules and regulations of the Securities
and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the
standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged
to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding
of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s
internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material
misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures
included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included
evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation
of the financial statements. We believe that our audit provides a reasonable basis for our opinion.
/s/ Wolf & Company, P.C.
We have served as the Company's auditor since 2024.
Boston, MA
April 15, 2025
F-2
CERO THERAPEUTICS HOLDINGS, INC.
CONSOLIDATED
BALANCE SHEETS
December 31, December 31,
ASSETS
Current assets:
Deferred offering costs 112,232 -
Deferred offering costs, net of current portion 500,000 -
LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ DEFICIT
Current liabilities:
Common stock subscription deposit - 1,875
Short-term notes payable, net - 599,692
Earnout liability 20,000 -
Deemed dividend – common stock liability, 13,835 shares 85,500 -
Preferred stock warrant liability - 320,117
Operating lease liability, net of current portion 699,107 1,575,499
Commitments and contingencies
Convertible preferred stock, $0.0001 par value per share, issuable in series:
Total convertible preferred stock - 42,101,344
Stockholders’ deficit:
Stock subscription receivable (1,295,444 ) -
See
accompanying notes to the consolidated financial statements
Reflects a 1-for-100 reverse stock split effective
January 8, 2025
F-3