UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
☒
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended March 31, 2025
OR
☐
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from to
Commission
File Number 001-41600
BULLFROG
AI HOLDINGS, INC.
(Exact
name of registrant as specified in its charter)
Nevada
84-4786155
(State
or other jurisdiction of
incorporation
or organization)
(I.R.S.
Employer
Identification
No.)
325
Ellington Blvd. , Unit 317
Gaithersburg ,
MD 20878
(Address
of principal executive offices) (Zip Code)
Registrant’s
telephone number, including area code: (240) 658-6710
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer
☐
Accelerated
Filer
☐
Non-accelerated
filer
☒
Smaller
reporting company
☒
Emerging
Growth Company
☒
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act) Yes ☐ No ☒
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class
Trading
symbol
Name
of each exchange on which registered
Common
Stock $0.00001 par value per share
BFRG
The
Nasdaq Stock Market LLC (The Nasdaq Capital Market)
Tradeable
Warrants
BFRGW
The
Nasdaq Stock Market LLC (The Nasdaq Capital Market)
The
number of shares of the registrant’s common stock issued and outstanding, as of May 12, 2025 was 9,415,525 .
BULLFROG
AI HOLDINGS, INC.
TABLE
OF CONTENTS FOR FORM 10-Q
PART
I.
FINANCIAL INFORMATION
Item
1.
Financial Statements
Condensed Consolidated Balance Sheets (unaudited)
2
Condensed Consolidated Statements of Operations (unaudited)
3
Condensed Consolidated Statements of Changes in Stockholders’ Equity (unaudited)
4
Condensed Consolidated Statements of Cash Flows (unaudited)
5
Notes to Condensed Consolidated Financial Statements (unaudited)
6
Item
2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
15
Item
3.
Quantitative and Qualitative Disclosures About Market Risk
19
Item
4.
Controls and Procedures
20
PART
II.
OTHER INFORMATION
21
Item
1.
Legal Proceedings
21
Item
1A.
Risk Factors
21
Item
2.
Unregistered Sales of Equity Securities and Use of Proceeds
21
Item
3.
Defaults Upon Senior Securities
21
Item
4.
Mine Safety Disclosures
21
Item
5.
Other Information
21
Item
6.
Exhibits
21
SIGNATURES
22
i
FORWARD-LOOKING
STATEMENTS
This
report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, or the “Securities
Act,” and Section 21E of the Securities Exchange Act of 1934 or the “Exchange Act.” These forward-looking statements
are subject to certain risks and uncertainties that could cause actual results to differ materially from historical results or anticipated
results.
In
some cases, you can identify forward-looking statements by terms such as “may,” “intend,” “might,”
“will,” “should,” “could,” “would,” “expect,” “believe,” “anticipate,”
“estimate,” “predict,” “potential,” or the negative of these terms. These terms and similar expressions
are intended to identify forward-looking statements. The forward-looking statements in this report are based upon management’s
current expectations and beliefs, which management believes are reasonable. In addition, we cannot assess the impact of each factor on
our business or the extent to which any factor or combination of factors, or factors we are unaware of, may cause actual results to differ
materially from those contained in any forward-looking statements. You are cautioned not to place undue reliance on any forward-looking
statements. These statements represent our estimates and assumptions only as of the date of this report. Except to the extent required
by federal securities laws, we undertake no obligation to update any forward-looking statement to reflect events or circumstances after
the date hereof or to reflect the occurrence of unanticipated events.
You
should be aware that our actual results could differ materially from those contained in the forward-looking statements due to a number
of factors, including:
● our
future financial performance, including our revenue, costs of revenue, operating expenses
and profitability;
● the
sufficiency of our cash and cash equivalents to meet our liquidity needs;
● our
predictions about, and the development of, digital transformation technology and bio health
businesses and their respective market trends;
● our
ability to attract and retain customers for our products and services;
● the
availability of financing for smaller publicly traded companies like us;
● our
current and future capital requirements to support the continued development and commercialization
of our products and services;
● our
ability to successfully expand in our three principal business markets and into new markets
and industry verticals; and
● our
ability to effectively manage our growth and future expenses.
Other
risks and uncertainties include such factors, among others, as market acceptance and market demand for our products and services, pricing,
the changing regulatory environment, the effect of our accounting policies, industry trends, adequacy of our financial resources to execute
our business plan, our ability to attract, retain and motivate key personnel, and other risks described from time to time in periodic
and current reports we file with the United States Securities and Exchange Commission, or the “SEC.” You should consider
carefully the statements under this report, which address additional factors that could cause our actual results to differ from those
set forth in the forward-looking statements and could materially and adversely affect our business, operating results and financial condition.
All subsequent written and oral forward-looking statements attributable to us or persons acting on our behalf are expressly qualified
in their entirety by the applicable cautionary statements.
1
PART
1. FINANCIAL INFORMATION
Item
1. Financial Statements
Bullfrog
AI Holdings, Inc.
Condensed
Consolidated Balance Sheets
(Unaudited)
March 31, 2025
December 31, 2024
Assets
Current assets
Cash and cash equivalents
$ 3,801,928
$ 5,435,983
Prepaid expenses
280,126
111,597
Total current assets
4,082,054
5,547,580
Property and equipment, net
3,818
4,250
Total assets
$ 4,085,872
$ 5,551,830
Liabilities and Stockholders’ Equity
Current liabilities
Accounts payable
$ 210,533
$ 435,934
Accrued expenses
464,794
152,156
Short term insurance financing
164,070
-
Total current liabilities
839,397
588,090
Total liabilities
839,397
588,090
Stockholders’ equity
Series A Convertible Preferred stock, $ 0.00001 par value, 5,500,000 shares authorized; 73,449 shares issued and outstanding as of March 31, 2025 and December 31, 2024.
1
1
Common stock, $ 0.00001 par value, 100,000,000 shares authorized; 9,415,525 and 9,113,139 shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively.
94
91
Additional paid-in capital
22,057,489
21,757,204
Accumulated deficit
( 18,811,109 )
( 16,793,556 )
Total stockholders’ equity
3,246,475
4,963,740
Total liabilities and stockholders’ equity
$ 4,085,872
$ 5,551,830
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
2
Bullfrog
AI Holdings, Inc.
Condensed
Consolidated Statements of Operations
(Unaudited)
2025
2024
Three Months Ended
March 31,
2025
2024
Revenue
Revenue
$ -
$ -
Total revenue
-
-
Cost of goods sold
Cost of goods sold
-
-
Total cost of goods sold
-
-
Gross profit
-
-
Operating expenses
Research and development
576,260
552,126
General and administrative
1,480,360
1,413,592
Total operating expenses
2,056,620
1,965,718
Loss from operations
( 2,056,620 )
( 1,965,718 )
Other income (expense), net
Interest expense, net
( 1,015 )
( 3,273 )
Interest income
40,082
65,197
Total other income (expense), net
39,067
61,924
Net loss
( 2,017,553 )
( 1,903,794 )
Deemed dividend related to warrant exercise price adjustment
-
( 16,774 )
Net loss attributable to common stockholders
$ ( 2,017,553 )
$ ( 1,920,568 )
Net loss per common share attributable to common stockholders - basic and diluted
$ ( 0.21 )
$ ( 0.26 )
Weighted average number of shares outstanding - basic and diluted
9,689,812
7,388,508
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
3
Bullfrog
AI Holdings, Inc.
Condensed
Consolidated Statements of Changes in Stockholders’ Equity
(Unaudited)
Shares
Amount
Shares
Amount
Capital
Deficit
Equity
Series A Preferred Stock
Common Stock
Additional Paid-in
Accumulated
Total Stockholders’
Shares
Amount
Shares
Amount
Capital
Deficit
Equity
Balance at December 31, 2023
73,449
$ 1
6,094,644
$ 61
$ 12,347,098
$ ( 9,754,924 )
$ 2,592,236
Stock-based compensation
-
-
-
-
335,417
-
335,417
Issuance of common stock and warrants, net of issuance costs
-
-
1,247,092
13
5,674,638
-
5,674,651
Issuance of common stock pursuant to warrant exercises
-
-
508,814
5
105,811
-
105,816
Deemed dividend related to warrant price adjustment
-
-
-
-
16,774
( 16,774 )
-
Net loss
-
-
-
-
-
( 1,903,794 )
( 1,903,794 )
Balance at March 31, 2024
73,449
$ 1
7,850,550
$ 79
$ 18,479,738
$ ( 11,675,492 )
$ 6,804,326
Balance at December 31, 2024
73,449
$ 1
9,113,139
$ 91
$ 21,757,204
$ ( 16,793,556 )
$ 4,963,740
Balance
73,449
$ 1
9,113,139
$ 91
$ 21,757,204
$ ( 16,793,556 )
$ 4,963,740
Stock-based compensation
-
-
-
-
300,288
-
300,288
Issuance of common stock pursuant to warrant exercises
-
-
302,386
3
( 3 )
-
-
Net loss
-
-
-
-
-
( 2,017,553 )
( 2,017,553 )
Balance at March 31, 2025
73,449
$ 1
9,415,525
$ 94
$ 22,057,489
$ ( 18,811,109 )
$ 3,246,475
Balance
73,449
$ 1
9,415,525
$ 94
$ 22,057,489
$ ( 18,811,109 )
$ 3,246,475
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
4
Bullfrog
AI Holdings, Inc.
Condensed
Consolidated Statements of Cash Flows
(Unaudited)
2025
2024
Three Months Ended March 31,
2025
2024
Cash flows from operating activities:
Net loss
$ ( 2,017,553 )
$ ( 1,903,794 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation
431
431
Stock-based compensation
300,288
335,417
Changes in operating assets and liabilities:
Prepaid expenses
( 168,529 )
( 486,714 )
Accounts payable
( 225,400 )
50,886
Accrued expenses
312,638
102,140
Net cash used in operating activities
( 1,798,125 )
( 1,901,634 )
Cash flows from investing activities:
Purchases of property and equipment
-
-
Net cash used in investing activities
-
-
Cash flows from financing activities:
Proceeds from issuance of common stock and warrants, net of issuance costs
-
5,674,651
Proceeds from warrant exercises
-
105,816
Proceeds from short term insurance financing
181,797
561,885
Payments on short term insurance financing
( 17,727 )
( 54,731 )
Net cash provided by financing activities
164,070
6,287,621
Net (decrease) increase in cash and cash equivalents
( 1,634,055 )
4,385,987
Cash and cash equivalents, beginning of period
5,435,983
2,624,730
Cash and cash equivalents, end of period
$ 3,801,928
$ 7,010,717
Supplemental cash flow information:
Cash paid for interest
$ 1,015
$ 3,273
Cash paid for taxes
$ -
$ -
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
5
Bullfrog
AI Holdings, Inc.
Notes
to Condensed Consolidated Financial Statements (Unaudited)
1. Organization and Nature of Business
Description
of Business
Bullfrog
AI Holdings, Inc. (“we”, “our” or the “Company”) was incorporated in the State of Nevada on February
6, 2020. Bullfrog AI Holdings, Inc. is the parent company of Bullfrog AI, Inc. and Bullfrog AI Management, LLC, which were incorporated
in Delaware and Maryland, in 2017 and 2021, respectively. All the Company’s operations are currently conducted through Bullfrog
AI Holdings, Inc., which began operations on February 6, 2020. The Company is focused specifically on advanced artificial intelligence
and machine learning (“AI/ML”) driven analysis of complex data sets in medicine and healthcare. The Company’s objective
is to utilize its AI/ML platform to provide a precision medicine approach to drug asset enablement through external partnerships and
selective internal development.
Most
new therapeutics will fail at some point in preclinical or clinical development. These failures are the primary drivers for the high
cost of developing new therapeutics. A major part of the difficulty in developing new therapeutics is efficient integration of complex
and highly dimensional data generated at each stage of development to de-risk subsequent stages of the development process. Artificial
intelligence and machine learning has emerged as a digital solution to help address this problem.
The
Company uses AI/ML to advance medicines for both internal and external projects. Most current AI/ML platforms still fall short in their
ability to synthesize disparate, high-dimensional data for actionable insight. The Company’s analytical platform is composed of
an ensemble of state-of-the-art machine learning and artificial intelligence models. The Company’s core platform technology, named
bfLEAP™, is an analytical AI/ML platform developed at The Johns Hopkins University Applied Physics Laboratory (“JHU-APL”),
which the Company believes is able to surmount the challenges of scalability and flexibility currently hindering researchers and clinicians
by providing a more precise, multi-dimensional understanding of their data. The Company is deploying its analytical platform, including
bfLEAP™, for use in several critical stages of development of internal programs and through strategic partnerships and collaborations
with the intention of streamlining data analytics in therapeutics development, decreasing the overall development costs by decreasing
failure rates for new therapeutics, and impacting the lives of countless patients that may otherwise not receive the therapies they need.
The
proprietary analytical platform utilizes both supervised and unsupervised machine learning. As such, it is able to reveal real and meaningful
connections in the data without the need for a priori hypothesis. Algorithms used in the platform are designed to handle highly imbalanced
data sets and successfully identify combinations of factors that are associated with outcomes of interest. The Company’s platform
leverages models that use both correlative and causative machine learning and artificial intelligence approaches which provide a comprehensive
approach to predictive analysis that is expected to lead to meaningful insights including the molecular drivers of disease. In this regard,
with the Company’s access to proprietary data sets such as its strategic data and commercialization agreements with the Lieber
Institute for Brain Development (“LIBD”), the Company has increased its internal efforts on target discovery.
The
Company’s goal is to improve the odds of success at all stages of pre-clinical and clinical therapeutics development for in-house
programs and for its strategic partners, collaborators, and customers. The Company’s business model includes enabling the success
of ongoing clinical trials and rescuing late stage failed drugs (i.e., Phase II or Phase III clinical trial failures) by bringing them
in-house for development prior to eventual divestiture; although, the Company also considers entering collaborations for earlier stage
drugs. The Company pursues its drug asset enhancement business by leveraging the powerful and proven bfLEAP™ AI/ML platform initially
developed at JHU-APL. The Company believes the bfLEAP™ analytics platform is a potentially disruptive tool for analysis of pre-clinical
and clinical data sets, such as the robust pre-clinical and clinical trial data sets being generated in translational R&D and clinical
trial settings.
Liquidity
and Going Concern
The
Company has had negative cash flows from operations and operated at a net loss since inception. As of March 31, 2025, the Company has
a cash balance of approximately $ 3.8 million. In February 2024 and October 2024, the Company received net proceeds of approximately $ 5.7
million and $ 2.7 million, respectively, from the sale of its common stock and warrants. As of March 31, 2025, the Company’s cash
and cash equivalents position is not sufficient to fund the Company’s planned operations for at least a year beyond the filing
date of the unaudited condensed consolidated financial statements. These factors raise substantial doubt about the Company’s ability
to continue as a going concern. The ability to continue as a going concern is dependent upon the Company obtaining the necessary financing
or revenues to meet its obligations arising from normal business operations when they become due.
6
Accordingly,
the Company will require additional capital to continue to execute its strategy. The Company anticipates raising this additional capital
through various avenues including sales of equity securities, debt transactions, licensing agreements and collaborative arrangements.
Although management believes that such funding sources will be available, including pursuant to the Company’s at-the-market common
stock sales facility entered into with BTIG, LLC in April 2025, there can be no assurance that any such arrangements will be consummated
or provide sufficient capital when needed to allow the Company to continue its operations, or if available, be on terms acceptable to
it. If the Company does not raise sufficient funds in a timely manner, among other things, it may be forced to delay, scale back or eliminate
some or all of its research and product development programs and/or capital expenditures or to enter into arrangements on unfavorable
terms. The Company currently does not have commitments for future funding from any source.
The
accompanying unaudited condensed consolidated financial statements have been prepared assuming that the Company will continue as a going
concern, which contemplates continuity of operations, realization of assets, and satisfaction of liabilities in the ordinary course of
business. Accordingly, these unaudited condensed consolidated financial statements do not include any adjustments that might result from
the outcome of this uncertainty.
2. Summary of Significant Accounting Policies
Other
than as noted below, the Company’s significant accounting policies as disclosed in the notes to its audited consolidated financial
statements included in the Annual Report on Form 10-K for the fiscal year ended December 31, 2024 have not materially changed during
the three months ended March 31, 2025.
Basis
of Presentation
The
accompanying unaudited condensed consolidated financial statements include the accounts of Bullfrog AI Holdings, Inc. and its wholly
owned subsidiaries and have been prepared in conformity with United States generally accepted accounting principles (“GAAP”)
for interim financial information. All intercompany accounts and transactions have been eliminated in consolidation.
The
condensed consolidated statements are unaudited and should be read in conjunction with the consolidated financial statements and related
notes included in the Company’s 2024 Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 14,
2025. The unaudited condensed consolidated financial statements have been prepared on a basis consistent with the audited annual consolidated
financial statements included in the Form 10-K and, in the opinion of management, include all adjustments of a normal recurring nature
necessary to fairly state its financial position, results of operations, and cash flows.
The
results for the three months ended March 31, 2025 are not necessarily indicative of the operating results expected for the year ending
December 31, 2025 or any other future period.
Segment
Reporting
The
Company’s chief operating decision maker (“CODM”) is the Company’s Chief Executive Officer. The CODM is assisted
in his responsibilities of making decisions regarding resource allocation and performance assessment by the leadership team, consisting
of executives and vice presidents.
The
Company views its operations and manages its business as one operating segment, focused on advancing drug development using AI/ML to
analyze complex data sets in medicine and healthcare. Segment profit or loss is measured as the Company’s net loss as reported
on the Company’s Statement of Operations. The Company monitors its cash and cash equivalents, as reported on the Company’s
Balance Sheets, to determine funding for its research and development.
As
the Company did not generate revenues in 2024 or through the first quarter of 2025, the CODM assessed Company performance through the
achievement of target identification goals. In addition to the Company’s Statement of Operations, the CODM is regularly provided
with budgeted and forecasted expense information which is used to determine the Company’s liquidity needs and cash allocation.
7
Revenue
Recognition
The
Company recognizes revenue based on the following five step model:
● Identification
of the contract with a customer
This
step outlines the criteria that must be met when establishing a contract with a customer to supply goods or services.
● Identification
of the performance obligations in the contract
This
step describes how distinct performance obligations in the contract must be handled.
● Determination
of the transaction price
This
step outlines what must be considered when establishing the transaction price, which is the amount the business expects to receive for
transferring the goods and services to the customer.
● Allocation
of the transaction price to the performance obligations in the contract
This
step outlines guidelines for allocating the transaction price across the contract’s separate performance obligations, and is what
the customer agrees to pay for the goods and services.
● Recognition
of revenue when, or as, the Company satisfies a performance obligation
Revenue
can be recognized as the business meets each performance obligation. This step specifies how that should happen.
Contract
Services
The
Company anticipates that the majority of its revenues to be recognized in the near future will result from discovery and monetization
of new drug targets and intellectual property from data use partnerships focused on analysis of rich proprietary data sets. The target
market for monetization will primarily be mid-size to large biopharmaceutical organizations seeking to build their new drug target pipeline.
A secondary revenue channel is fee-for-service partnerships with biopharmaceutical companies and other organizations of all sizes that
have challenges analyzing data throughout the drug development process. The Company provides the customer with an analysis of large complex
data sets using the Company’s proprietary AI/ML platform. This platform is aimed at predicting targets of interest, patterns, relationships,
anomalies, and molecular drivers of disease. The Company believes that there will be additional on-going work requested from partners;
therefore, the service model utilizes a master services agreement with work or task orders issued for discrete analysis performed at
the discovery, preclinical, or clinical stages of drug development. The Company will receive fees in cash, equity or other consideration
and, in some instances, the potential for rights to new intellectual property generated from the analysis. Once data analysis and the
analysis report are complete, the Company delivers the analysis set to the customer and recognizes revenue at that point in time.
Recent
Accounting Pronouncements
In
December 2023, the FASB issued ASU No. 2023-09: Income Taxes (Topic 740): Improvements to Income Tax Disclosures that requires
entities to disclose additional information about federal, state, and foreign income taxes primarily related to the income tax rate reconciliation
and income taxes paid. The new standard also eliminates certain existing disclosure requirements related to uncertain tax positions and
unrecognized deferred tax liabilities. The guidance is effective for the Company’s fiscal year ending December 31, 2025. The guidance
does not affect recognition or measurement in the Company’s consolidated financial statements.
The
Company does not believe that any other recently issued effective pronouncements, or pronouncements issued but not yet effective, if
adopted, would have a material effect on the accompanying financial statements.
3. Notes Payable
In
February 2025, the Company entered into an agreement to finance a portion of the premium for its directors and officers insurance. The
agreement provides for financing of $ 181,797 of the premium, repayments in 10 equal monthly installments of $ 18,743 each through December
2025 and accrues interest at 6.70 %.
In
February 2024, the Company entered into an agreement to finance a portion of the premium for its directors and officers insurance. The
agreement provided for financing of $ 561,885 of the premium, repayments in 10 equal monthly installments of $ 58,005 each through December
2024 and accrued interest at 6.99 %. The note was repaid in its entirety in 2024.
8
4. Stockholders’ Equity
Preferred
Stock
The
Company has 10,000,000 shares of preferred stock authorized at a par value of $ 0.00001 with 5,500,000 being designated as Series A Convertible
Preferred Stock. Of the 5,500,000 authorized shares of Series A Convertible Preferred Stock, 73,449 were issued and outstanding as of
March 31, 2025. Each share of Series A Convertible Preferred Stock is convertible at any time into 10 shares of the Company’s common
stock. The Series A Preferred Stock is the economic equivalent of the common stock but has no voting rights and is subject to a blocker
which prohibits the conversion into common stock if it would result in the investor owning more than 4.99 % of the Company’s outstanding
common stock at such time.
Common
Stock
The
Company has 100,000,000 shares of common stock authorized at a par value of $ 0.00001 .
In
February 2024, the Company received approximately $ 6.5
million of gross proceeds from the sale of 1,247,092
shares of common stock, 478,429
pre-funded warrants and 1,725,521
common warrants (each share of common stock or pre-funded warrant and common warrant, collectively, the “Units”). The
Units were sold at a price of $ 3.782
and the sale was completed via an underwritten public offering and includes the underwriter’s exercise of their overallotment
option. The warrants have an exercise price of $ 4.16
and expire 5
five-years from issuance. In conjunction with the transaction, the Company issued to the placement agent warrants to purchase an
aggregate of 90,428
shares of common stock. The placement agent warrants have an exercise price of $ 4.16
and expire 5 five-years from issuance. The pre-funded warrants had an exercise price of $ 0.001
and were all exercised in their entirety in the first quarter of 2024.
In
October 2024, the Company received approximately $ 3.13
million of gross proceeds from the sale of (i) 862,602
shares of the Company’s common stock and pre-funded warrants to purchase up to 702,398
shares of common stock with an exercise price of $ 0.0001
per share, at a purchase price of $ 2.00
per share of common stock and a purchase price of $ 1.9999
per pre-funded warrant in a registered direct offering and (ii) warrants to purchase an aggregate of 1,565,000
shares of common stock with an exercise price of $ 2.00
per share exercisable after six (6) months from the date of issuance for a 5 five-year period from the initial exercise date in a
concurrent private placement. In conjunction with the transactions, the Company paid the placement agent an aggregate cash fee of
8.0% of the gross proceeds from the sale of securities in the transaction, reimbursed the placement agent for certain out-of-pocket
expenses and issued to the placement agent warrants to purchase an aggregate of 62,600 shares of common stock, equal to 4% of the
aggregate number of shares of common stock and pre-funded warrants sold in the registered direct offering. The placement agent
warrants have an exercise price of $2.00 per share and are exercisable six (6) months from the date of issuance for a five-year
period from the initial exercise date. As of March 31, 2025, all the pre-funded warrants were exercised in cashless transactions and
702,373 shares of common stock were issued.
Dilutive
securities are excluded from the diluted earnings per share calculation because their effect is anti-dilutive. As of March 31, 2025,
73,449 shares of preferred stock, 6,935,042 warrants and 938,927 options for common shares were excluded from the calculation of net
loss per share. As of March 31, 2024, 73,449 shares of preferred stock, 5,307,444 warrants and 826,717 options for common shares were
excluded from the calculation of net loss per share. For each of the three months ended March 31,
2025 and March 31, 2024, 274,286 pre-funded warrants issued in 2020 as consideration for services were
included in the calculation of net loss per common share.
9
2022
Equity Incentive Plan
In
November 2022, the Company’s Board of Directors adopted, and its shareholders approved the 2022 Equity Incentive Plan (the “Plan”).
The Plan provides for the granting of equity-based awards to employees, directors, and consultants. The Plan provides for equity-based
awards including incentive stock options, non-qualified stock options, stock appreciation rights, performance share awards, cash awards
and other equity-based awards. Awards are limited to a maximum term of 10 years and any exercise prices shall not be less than 100% of
the fair market value of one share of common stock on the grant date. The Plan authorized an initial maximum number of shares underlying
awards of 900,000 with an automatic annual increase to an amount equal to 15 % of the total number of shares outstanding as of the end
of the preceding fiscal year. As of March 31, 2025, there are 497,260 awards authorized but unissued available under the Plan.
Stock
Options
The
following tables summarize the stock option activity for the three months ended March 31, 2025 and 2024:
Schedule of Stock Options Activity
Number of Shares
Weighted-Average Exercise Price
Weighted-Average Remaining Contractual Term (Years)
Aggregate Intrinsic Value
Outstanding at December 31, 2024
832,731
$ 3.96
8.5
$ -
Granted
211,500
$ 2.19
Exercised
-
$ -
Forfeited / canceled
( 105,304 )
$ 3.84
Outstanding at March 31, 2025
938,927
$ 3.57
8.6
$ -
Vested at March 31, 2025
608,934
$ 3.87
8.1
$ -
Number of Shares
Weighted-Average Exercise Price
Weighted-Average Remaining Contractual Term (Years)
Aggregate Intrinsic Value
Outstanding at December 31, 2023
527,717
$ 4.17
9.0
$ 112,141
Granted
299,000
$ 3.90
Exercised
-
$ -
Forfeited / canceled
-
$ -
Outstanding at March 31, 2024
826,717
$ 4.07
9.1
$ 100,452
Vested at March 31, 2024
356,505
$ 4.02
8.6
$ 63,272
The
fair value of options granted in the three months ended March 31, 2025 and 2024 was estimated using the Black-Scholes option pricing
model based on the assumptions in the table below:
Schedule of Black Scholes Option Pricing Model
Three Months Ended March 31,
2025
2024
Expected dividend yield
0 %
0 %
Expected volatility
94 % - 96 %
91 % - 95 %
Risk-free interest rate
4.0 % - 4.5 %
4.0 % - 4.3 %
Expected life (in years)
5.5
5.25 - 6.0
● Volatility
– The trading volatility was determined by calculating the volatility of the Company’s
peer group.
● Expected
life of options – The expected life of options granted to employees was determined
using the simplified method.
● Risk-free
interest rate – This is the U.S. Treasury rate, having a term comparable to the
expected life of the stock option.
● Dividend
yield – The Company does not expect to pay a dividend in the foreseeable future.
The
weighted-average grant-date fair value of options granted during the three months ended March 31, 2025 and 2024 were $ 1.67 and $ 2.97 ,
respectively.
10
During
the three months ended March 31, 2025 and 2024, the Company recognized $ 300,288 and $ 333,020 , respectively, of compensation expense related
to stock options.
As
of March 31, 2025, the total unrecognized compensation expense related to unvested stock options was approximately $ 238,000 , which the
Company expects to recognize over a weighted-average period of approximately 1.8 years.
Warrants
The
following table provides details over the Company’s outstanding warrants of March 31, 2025:
Schedule
of Outstanding Warrants
Exercise Price
Expiration
Number of Warrants
$ 0.0007
2030
274,286
$ 2.00 - $ 2.66
2026 - 2032
2,164,179
$ 3.36 - $ 4.16
2028 - 2029
1,842,807
$ 6.51 - $ 7.80
2026 - 2032
1,484,829
$ 8.125
2028
1,443,227
7,209,328
Warrants
Issued in Conjunction with Transactions
During
the year ended December 31, 2024, the Company issued the following warrants as part of two offerings:
● In
February 2024, 1,507,139 warrants with an exercise price of $ 4.16 per share and an expiration
date 5 years from issuance. In addition, the Company issued an additional 218,382 warrants
with an exercise price of $ 4.16 per share and an expiration date 5 years from issuance pursuant
to the underwriters’ overallotment option. As of March 31, 2025, 16,000 of these warrants
have been exercised and 1,709,521 remain outstanding. As a result of this transaction, 90,419
warrants issued in connection with the Company’s 2023 IPO had their exercise prices
reduced to $ 3.782 per share pursuant to an anti-dilution provision in the warrants resulting
in a deemed dividend of $ 16,774 .
● In
February 2024, 478,429 pre-funded warrants with an exercise price of $ 0.0001 per share. All
such pre-funded warrants were exercised in 2024.
● In
February 2024, 90,428 warrants with an exercise price of $ 4.16 per share and an expiration
date 5 years from issuance to the underwriters. The warrants were valued at approximately
$ 263,145 , and as of March 31, 2025, none of these warrants have been exercised.
● In
October 2024, 1,565,000 warrants to purchase shares of the Company’s common stock at
an exercise price of $ 2.00 per share and expiration date of 5.5 years from issuance. As of
March 31, 2025, none of these warrants have been exercised. As a result of this transaction,
90,419 warrants issued in connection with the Company’s 2023 IPO had their exercise
prices further reduced to $ 2.00 per share pursuant to an anti-dilution provision in the warrants
resulting in a deemed dividend of $ 28,211 .
● In
October 2024, 702,398 pre-funded warrants with an exercise price of $ 0.0001 per share. As
of March 31, 2025, all such pre-funded warrants were exercised in cashless transactions and
702,373 shares of common stock were issued.
● In
October 2024, 62,600 warrants with an exercise price of $ 2.00 per share and an expiration
date 5.5 years from issuance to the placement agent. The warrants were valued at approximately
$ 116,436 and, as of March 31, 2025, none of these warrants have been exercised.
11
Warrants
Issued as Consideration for Services
The
following tables summarize the activity for warrants issued as consideration for services for the three months ended March 31, 2025 and
2024:
Schedule
of Warrant Activity
Number of Warrants
Weighted-Average Exercise Price
Weighted-Average Remaining Contractual Term (Years)
Aggregate Intrinsic Value
Outstanding at December 31, 2024
663,891
$ 1.55
5.6
$ 548,380
Granted
-
$ -
Exercised
-
$ -
Forfeited / canceled
-
$ -
Outstanding at March 31, 2025
663,891
$ 1.55
5.3
$ 452,380
Vested at March 31, 2025
663,891
$ 1.55
5.3
$ 452,380
Number of Warrants
Weighted-Average Exercise Price
Weighted-Average Remaining Contractual Term (Years)
Aggregate Intrinsic Value
Outstanding at December 31, 2023
678,176
$ 1.57
6.6
$ 1,209,136
Granted
-
$ -
Exercised
( 14,285 )
$ 2.66
Forfeited / canceled
-
$ -
Outstanding at March 31, 2024
663,891
$ 1.55
6.3
$ 1,170,302
Vested at March 31, 2024
660,910
$ 1.54
6.3
$ 1,168,664
During
the three months ended March 31, 2024, the Company recognized $ 2,397 of compensation expense related to warrants issued as consideration
for services. No such expense was recognized in the three months ended March 31, 2025.
As
of March 31, 2025, there was no unrecognized compensation expense as no unvested warrants remain.
5. Income Taxes
The
Company has not recorded any tax provision or benefit for the three months ended March 31, 2025 or 2024. The Company has provided a valuation
allowance for the full amount of its net deferred tax assets since realization of any future benefits from deductible temporary differences,
net operating losses, credit carryforwards, and research and development credits are not more-likely-than-not to be realized at March
31, 2025 and December 31, 2024.
6. Material Agreements
JHU-APL
Technology License
In
February 2018, the Company entered into an exclusive, world-wide, royalty-bearing license with JHU-APL (the “2018 License Agreement”).
The license covers three (3) issued patents, one (1) new provisional patent application, non-patent rights to proprietary libraries of
algorithms and other trade secrets, as well as modifications and improvements. In October 2021, the Company executed an amendment to
the original license for improvements and new advanced analytics capabilities. In consideration of the rights granted to the Company
under the 2018 License Agreement, JHU-APL received a warrant equal to five percent ( 5 %) of the then fully diluted equity base of the
Company, which was diluted following the closing of the Company’s initial public offering.
12
In
July 2022, the Company entered into an exclusive, world-wide, royalty-bearing license from JHU-APL for the additional technology developed
to enhance the bfLEAP™ platform (the “2022 License Agreement”). The new license provides additional intellectual property
rights including patents, copyrights, and know-how to be utilized under the Company’s bfLEAP™ analytical AI/ML platform.
This 2022 License Agreement supersedes the previous 2018 License Agreement. In consideration for entering into the new license, the Company
issued 39,879 shares of common stock to JHU-APL. Under the terms of the 2022 License Agreement, JHU-APL will be entitled to eight percent
( 8 %) of net sales for the services provided by the Company to other parties and three percent ( 3 %) for internally developed drug projects
in which the JHU-APL license is utilized. The new license also contains tiered sub licensing fees that start at 50 % and decline to 25 %
based on revenues. In addition, under the 2022 License Agreement, the minimum annual royalty payments are $ 30,000 for 2022, $ 80,000 for
2023, and $ 300,000 per year for 2024 and beyond, all of which are creditable by royalties. If cumulative annual royalty payments do not
reach these levels, the amount due to JHU-APL to reach the annual minimum is due by January 1 st of the following year. Failure
to make annual royalty payments is considered a material breach under the agreement and, upon notice from JHU-APL of a material breach,
the Company will have 60 days to cure the material breach. The financial terms of the new license agreement replace the original terms
within the 2018 License Agreement and are not duplicative.
In
May 2023, the Company and JHU-APL entered into Amendment Number 1 of the 2022 License Agreement whereby the Company gained access to
certain improvements including additional patents and know-how in exchange for a series of payments totaling $ 275,000 . The first of these
payments for $ 75,000 was paid in July 2023 and the remaining payments of $ 75,000 , $ 75,000 , and $ 50,000 are due in years 2025, 2026 and
2027, respectively. The amendment also reduced the 2023 minimum annual royalty payment to $ 60,000 , all other financial terms remain the
same.
As
of March 31, 2025, all minimum annual royalty payments through 2024 have been paid, the Company has accrued $ 75,000 of the $ 300,000 minimum
annual royalty for 2025, and the Company has accrued $ 45,000 of the $ 75,000 annual license fee due in June 2025. The Company assessed
whether the license should be capitalized and determined that the licensed program is in the early stage and therefore may not be recoverable.
The Company expensed the license fee and will expense development costs until commercial viability is likely.
George
Washington University - Beta2-spectrin siRNA License
In
January 2022, the Company entered into an exclusive, world-wide, royalty-bearing license from George Washington University (“GWU”)
for rights to use siRNA targeting Beta2-spectrin in the treatment of human diseases, including hepatocellular carcinoma. The license
covers methods claimed in three U.S. and worldwide patent applications, and also includes use of this approach for treatment of obesity,
non-alcoholic fatty liver disease, and non-alcoholic steatohepatitis.
In
consideration of the rights granted to the Company under the license agreement, the Company paid GWU a $ 20,000 license initiation fee
in 2022. Under the terms of the license agreement, GWU will be entitled to a three percent ( 3 %) royalty on net sales subject to quarterly
minimums once the first sale has occurred subsequent to regulatory approval, as well sublicense or assignment fees in the event the Company
sublicenses or assigns their rights to use the technology. The Company will also reimburse GWU for previously incurred and ongoing patent
costs. The sublicense and assignment fee amounts decline as the Company advances the clinical development of the licensed technology.
The license agreement also contains milestone payments for clinical development through the approval of a new drug application (“NDA”)
by the U.S. Food and Drug Administration and commercialization. As of March 31, 2025, there has been no accrual for royalties since the
Company has not begun to generate applicable revenue; however, the Company has accrued $ 5,000 of the $ 20,000 license maintenance fees
for 2025. The Company assessed whether the license should be capitalized and determined that the licensed program is in the early stage
and therefore may not be recoverable. The Company expensed the license fee and will expense development costs until commercial viability
is likely.
Johns
Hopkins University – Mebendazole License
In
February 2022, the Company entered into an exclusive, world-wide, royalty-bearing license from Johns Hopkins University (“JHU”)
for the use of an improved formulation of Mebendazole for the treatment of any human cancer or neoplastic disease. This formulation shows
potent activity in animal models with different types of cancer and has been evaluated in a Phase I clinical trial in patients with high-grade
glioma (NCT01729260). The trial, an open-label dose-escalation study, assessed the safety and efficacy of the improved formulation with
adjuvant temozolomide in 24 patients with newly diagnosed gliomas. Investigators observed no dose-limiting toxicity in patients receiving
all but the highest tested dose (200mg/kg/day). Four of the 15 patients receiving the maximum tested dose of 200mg/kg/day experienced
dose-limiting toxicity, all of which were reversed by decreasing or eliminating the dose given. There were no serious adverse events
attributed to Mebendazole at any dose during the trial. 41.7% of patients who received Mebendazole were alive at two years after enrollment,
and 25% were alive at four years (Gallia et al., 2021).
13
The
license covers six (6) issued patents and one (1) pending application. In consideration of the rights granted to the Company under the
license agreement, JHU received a staggered upfront license fee of $ 250,000 , with $ 50,000 paid in 2022 and the remaining balance of $ 200,000
paid in 2023. The Company will also reimburse JHU for previously incurred and ongoing patent costs. Under the terms of the license agreement,
JHU will be entitled to three and one-half percent ( 3.5 %) royalty on net sales by the Company in which the JHU license was utilized.
In addition, the Company is required to pay JHU minimum annual royalty payments of $ 5,000 for 2022, $ 10,000 for 2023, $ 20,000 for 2024,
$ 30,000 for 2025 and $ 50,000 for 2026 and each year after until the first commercial sale, after which the annual minimum royalty shall
be $ 250,000 . The license agreement also contains milestone payments for clinical development steps through the approval of an NDA and
commercialization. As of March 31, 2025, the balance of accrued expense related to this license agreement was $ 7,500 of the $ 30,000 for
2025. The Company assessed whether the license should be capitalized and determined that the licensed program is in the early stage and
therefore may not be recoverable. The Company expensed the license fee and will expense development costs until commercial viability
is likely.
Johns
Hopkins University – Mebendazole Prodrug License
In
October 2022, the Company entered into an exclusive, world-wide, royalty-bearing license from JHU and the Institute of Organic Chemistry
and Biochemistry (“IOCB”) of the Czech Academy of Sciences for rights to commercialize N-substituted prodrugs of Mebendazole
that demonstrate improved solubility and bioavailability. The license covers prodrug compositions and use for treating disease as claimed
in multiple U.S. and worldwide patent applications. In consideration for the rights granted to the Company under the license agreement,
JHU and IOCB received a staggered upfront license fee of $ 100,000 and the Company reimbursed JHU and IOCB for previously incurred patent
costs. Under the terms of the license agreement, JHU and IOCB will be entitled to a four percent ( 4.0 %) royalty on net sales by the Company
in which the JHU and IOCB license was utilized. In addition, the Company is required to pay JHU and IOCB minimum annual royalty payments
of $ 5,000 for 2026, $ 10,000 for 2027, $ 20,000 for 2028, $ 30,000 for 2029 and $ 50,000 for 2030 and each year after until the first commercial
sale, after which, the annual minimum royalty shall be $ 150,000 . The license agreement also contains milestone payments for patent grants,
clinical development steps through the approval of an NDA and commercialization. As of March 31, 2025, the balance of accrued expense
related to this license agreement was $ 0 . The Company assessed whether the license should be capitalized and determined that the licensed
program is in the early stage and therefore may not be recoverable. The Company will expense the license fee and development costs until
commercial viability is likely.
7. Subsequent Events
The
Company evaluates subsequent events and transactions that occur after the balance sheet date up to the date that the unaudited condensed
consolidated financial statements are issued.
Other
than as disclosed in this Note 7 and as may be disclosed elsewhere in the notes to the accompanying unaudited condensed consolidated
financial statements, there have been no subsequent events that require adjustment or disclosure in the accompanying unaudited condensed
consolidated financial statements.
On
April 25, 2025, the Company entered into an At-The-Market Sales Agreement (the “ATM Agreement”) with BTIG, LLC, pursuant
to which the Company may offer and sell, from time to time in its sole discretion, shares of common stock having an aggregate offering
price of $ 20 million through BTIG, as the Company’s sales agent. The Company is not obligated to make any sales of common stock
under the ATM Agreement, and BTIG is not required to sell any specific number or dollar amount of shares. Subject to the Company’s
request to sell shares of common stock, BTIG will use commercially reasonable efforts, consistent with its normal trading and sales practices,
to sell such shares on the Company’s behalf. The Company will pay BTIG a commission of 3 % of the gross sales price of any shares
of common stock sold through BTIG under the ATM Agreement.
14
Item 2. Management’s Discussion and Analysis of Financial Conditions and Results of Operations
References
in this Management’s Discussion and Analysis of Financial Condition and Results of Operations to “us”, “we”,
“our” and similar terms refer to the Company. The following discussion and analysis of our financial condition and results
of operations should be read in conjunction with (1) our unaudited condensed consolidated financial statements and related notes included
elsewhere in this Quarterly Report on Form 10-Q, and (2) our consolidated financial statements, related notes and management’s
discussion and analysis of financial condition and results of operations in our Annual Report on Form 10-K for the year ended December
31, 2024, filed with the Securities and Exchange Commission on March 14, 2025. This Form 10-Q contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange
Act of 1934, as amended, or the Exchange Act. These statements are often identified by the use of words such as “anticipate,”
“believe,” “continue,” “could,” “estimate,” “expect,” “intend,”
“may,” “plan,” “project,” “will,” “would” or the negative or plural of these
words or similar expressions or variations. Such forward-looking statements are subject to a number of risks, uncertainties, assumptions,
and other factors that could cause actual results and the timing of certain events to differ materially from future results expressed
or implied by the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited
to, those identified herein. You should not rely upon forward-looking statements as predictions of future events. Furthermore, such forward-looking
statements speak only as of the date of this report. Except as required by law, we undertake no obligation to update any forward-looking
statements to reflect events or circumstances after the date of such statements.
Overview
Bullfrog
AI Holdings, Inc. was incorporated in the State of Nevada in February 2020. Bullfrog AI Holdings, Inc. is the parent company of Bullfrog
AI, Inc. and Bullfrog AI Management, LLC, which were incorporated in Delaware and Maryland, in 2017 and 2021, respectively. Operations
are currently conducted through Bullfrog AI Holdings, Inc., which began operations on February 6, 2020. We are a company focused specifically
on advanced Artificial Intelligence / Machine Learning (“AI/ML”) analysis of complex data in the advancement of medicine.
Our AI/ML platform (trade name: bfLEAP™) was created from technology originally developed at The Johns Hopkins University Applied
Physics Laboratory (“JHU-APL”). Subsequently, we have developed new tools and capabilities composed of an ensemble of machine
learning and artificial intelligence models.
In
February 2018, the Company secured an original exclusive, worldwide, royalty-bearing license from JHU-APL for the technology underlying
our bfLEAP™ platform. The license covers three (3) issued patents, one (1) new provisional patent application, non-patent rights
to proprietary libraries of algorithms and other trade secrets including modifications and improvements. We entered into a new license
agreement with JHU-APL in July 2022 that provides the Company with new intellectual property and also encompasses most of the intellectual
property from the February 2018 license. In consideration for the new license entered into in July 2022 with JHU-APL, the Company issued
to JHU-APL 39,879 shares of common stock. Under the terms of the new license agreement, JHU-APL will be entitled to eight (8%) percent
of net sales for the services provided by the Company to other parties and three (3%) percent for internally developed drug projects
in which the JHU-APL license was utilized. The new license also contains tiered sub licensing fees that start at fifty (50%) percent
and decline to twenty-five (25%) percent based on revenues. The Company and JHU-APL entered into Amendment Number 1 of the July 2022
license agreement pursuant to which the Company gained access to certain improvements including additional patents and know-how in exchange
for a series of payments totaling $275,000. The first of these payments of $75,000 was paid in July 2023 and the remaining payments of
$75,000, $75,000 and $50,000 are due in years 2025, 2026 and 2027, respectively. The amendment also reduced the 2023 minimum annual royalty
payment to $60,000. All other financial terms remain the same. As a result of this amendment, the minimum annual payments were $30,000
for 2022 and $60,000 for 2023, and the minimum annual payments will be $300,000 for 2024 and beyond, all of which are creditable against
royalties paid by us. As of March 31, 2025, all minimum annual royalty payments through 2024 have been paid, the Company has accrued
$75,000 of the $300,000 minimum annual royalty for 2025, and the Company has accrued $45,000 of the $75,000 annual license fee due in
June 2025.
Our
objective is to utilize bfLEAP™, our AI/ML platform, with a precision medicine approach toward drug development with biopharmaceutical
collaborators, as well as our own internal clinical development programs. We believe the bfLEAP™ platform is ideally suited for
evaluating pre-clinical and clinical trial data generated in translational research and clinical trial settings in order to lead to faster,
less expensive drug approvals.
15
Our
aim is to improve the odds of success in each stage of developing medicine, ranging from early pre-clinical through late-stage clinical
development. Our ultimate objective is to utilize bfLEAP™ to enable the success of ongoing third-party clinical trials or rescue
late-stage failed drugs (i.e., Phase II or Phase III clinical trial failures) for in-house development and divestiture. We will also
consider collaborations for earlier stage drugs.
We
intend to continue to evolve and improve bfLEAP™, either in-house or with development partners like JHU-APL. We plan to leverage
our proprietary AI/ML platform developed over several years at one of the top innovation institutions in the world, which has already
been successfully applied in multiple sectors.
We
operate and have staffed our business using funds from our initial public offering and subsequent financings, have entered into partnerships
and relationships, and completed our first commercial service contract with a leading rare disease non-profit organization for AI/ML
analysis of late-stage clinical data in 2023. We have also acquired the rights to a series of preclinical and early clinical drug assets
from universities, as well as entered into a strategic collaboration with a world-renowned research institution to create a HSV1 viral
therapeutic platform to engineer immunotherapies for a variety of diseases. We have signed exclusive worldwide license agreements with
Johns Hopkins University (“JHU”) for a cancer drug that targets glioblastoma (brain cancer), pancreatic cancer, and others.
We have also signed an exclusive worldwide license from George Washington University for another cancer drug that targets hepatocellular
carcinoma (liver cancer) and other liver diseases. In addition, we signed three-year strategic data and commercialization agreements
with the Lieber Institute for Brain Development (“LIBD”) whom we believe has a repository of the largest collection of postmortem
brains in the world, including molecular, clinical, and other data. The objective of this collaboration with LIBD is for the Company
to analyze these rich data sets using its proprietary AI/ML tools and models and then go to market with the discoveries with the ultimate
goal of securing revenue generating strategic partnership deals with biopharmaceutical companies. We intend to secure the rights to other
proprietary data sets and repeat this strategy. Additionally, we intend to gain access to later-stage clinical assets through partnerships
or the acquisition of rights to failed therapeutic candidates for drug rescue. In certain circumstances, we intend to conduct late-stage
clinical trials in an effort to rescue therapeutic assets that previously failed. In these cases, there will be a requirement for drug
supply and regulatory services to conduct clinical trials. The success of our clinical development programs will require finding partners
to support the clinical development, adequate availability of raw materials and drug product for our research and development and clinical
trials, and, in some cases, may also require the establishment of third-party arrangements to obtain finished drug product that is manufactured
appropriately under good manufacturing practices, and packaged for clinical use or sale. Since we are a company focused on using our
AI/ML technology to advance medicines, any clinical development programs will also require, in all cases, partners and the establishment
of third-party relationships for execution and completion of clinical trials.
Since
completing our initial public offering in February 2023 (the “IPO”), aided by the receipt of the IPO proceeds in addition
to the proceeds from our February 2024 and October 2024 offerings, we have implemented several initiatives including: investor relations
and marketing to raise awareness for the Company in the financial and business sectors, research and development, collaboration with
the J Craig Venter Institute (“JCVI”), and initiation of preclinical studies with our in-licensed drug programs. The Company
is actively engaged in developing and pursuing new intellectual property as it strives to continuously evolve its AI/ML platform.
Internally,
the Company has added incremental staff to accelerate execution and development of processes and custom scripts for use in performing
new drug target discovery and analytical services for customers, while also launching initiatives targeting large public health data
sources and seeking access to proprietary health data sources, such as our agreement with the LIBD. We are also transitioning our accounting
and financial reporting systems and processes to enhance our internal control environment as a public company. Capital from the IPO was
also used to retire two notes that were sold to fund the Company through the IPO as well as other debts accrued over time to our staff,
employees and consultants, and obligations related to the acquisition of our licensed drug programs.
16
The
Company has had negative cash flows from operations and operated at a net loss since inception. In the first quarter of 2023, we completed
our IPO. In February 2024, we received net proceeds of approximately $5.7 million from an underwritten public offering of common stock
and warrants. Additionally, in October 2024, we received net proceeds of approximately $2.7 million from a registered direct offering
of common stock and pre-funded warrants, and concurrent private placement of common stock warrants. As of March 31, 2025, the Company
has a cash balance of approximately $3.8 million. As of March 31, 2025, the Company’s cash and cash equivalents position is not
sufficient to fund the Company’s planned operations for at least a year beyond the filing date of the unaudited condensed consolidated
financial statements. These factors raise substantial doubt about the Company’s ability to continue as a going concern. The ability
to continue as a going concern is dependent upon the Company obtaining the necessary financing or revenues to meet its obligations arising
from normal business operations when they become due.
Accordingly,
we will require additional capital to continue to execute our strategy. We anticipate raising this additional capital through various
avenues including sales of equity securities, debt transactions, licensing agreements and collaborative arrangements. Although management
believes that such funding sources will be available, including pursuant to the Company’s at-the-market common stock sales facility
entered into with BTIG, LLC in April 2025, there can be no assurance that any such arrangements will be consummated or provide sufficient
capital when needed to allow us to continue our operations, or if available, be on terms acceptable to us. If we do not raise sufficient
funds in a timely manner, among other things, we may be forced to delay, scale back or eliminate some or all our research and product
development programs and/or our capital expenditures or to enter into arrangements on unfavorable terms. We currently do not have commitments
for future funding from any source.
Our
Strategy
The
Company has a unique strategy designed to reduce risk and increase the frequency of cash flow. The first part of the strategy is to generate
revenues through strategic relationships with biopharma companies. These relationships will be structured as a combination of fees in
cash, equity, or other consideration and intellectual property based on the specific scope of the engagement. The objective of these
engagements will be to uncover valuable insights to reduce the risk and increase the speed of the drug development process which can
be achieved through manual or automated integration into the client’s workflow or analysis of discrete data sets.
In
the future, the second part of our strategy involves acquiring the rights to drugs at various stages of development and using our proprietary
AI/ML technology to advance the development of such drugs, with the objective of creating near term value and then exiting and monetizing
as quickly as possible, preferably within approximately 30 months.
Critical
Accounting Policies and Estimates
Our
financial statements are prepared in accordance with U.S. GAAP. The preparation of these financial statements requires us to make estimates
and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses, as well as related disclosures. We evaluate
our estimates and assumptions on an ongoing basis. Our estimates are based on historical experience and various other assumptions that
we believe to be reasonable under the circumstances. Our actual results could differ from these estimates. There have been no material
changes to our critical accounting policies and estimates as those described in our Form 10-K.
Financial
Operations Overview
Revenue
We
completed our first commercial service contract and recognized revenue in the amount of $65,000 in the third quarter of 2023. We did
not recognize any revenue in 2024. In February 2025, we announced our entry into a collaboration agreement with Eleison Pharmaceuticals
Inc., a Phase III oncology company focused on novel chemotherapeutic treatments for rare cancers. We are in discussions with other potential
partners, although there can be no assurance of entering into other business relationships in 2025 or beyond. We did not generate any
revenue during the three months ended March 31, 2025.
17
Research
and Development Costs and Expenses
Research
and development costs and expenses include development activities on our licensed drug candidates and our discovery efforts and collaborations.
In addition to fees paid to external service providers, we are also allocating costs for internal personnel working on these activities
as well as their efforts to develop our product and service offerings using bfLEAP™. We anticipate our research and development
costs could become significant as we execute on our business plan and begin conducting preclinical research and development activities
directed at securing development partners and filing an investigational new drug (IND) application for our licensed drug development
programs described in this filing, as well as under strategic partnerships and for other drug development programs we may acquire. Research
and development expenses are recorded in operating expenses in the period in which they are incurred. Estimates will be used in determining
the expense liability of certain costs where services have been performed but not yet invoiced. We will monitor levels of performance
under each significant contract for external services through communications with the service providers to reflect the actual amount
expended.
General
and Administrative Expenses
General
and administrative expenses include personnel costs and costs associated with being a public company such as directors and officers (“D&O”)
insurance, audit and tax provider fees, legal fees, and exchange listing costs. Additionally, our general and administrative costs include
expenses for our business development, investor relations and marketing efforts. We anticipate our general and administrative expenses
increasing in the future to support our service offerings and clinical and pre-clinical research and development activities associated
with strategic partnering and collaborations.
Results
of Operations - Comparison of Three Months Ended March 31, 2025 and 2024
March 31,
Net Change
2025
2024
Operating expenses:
Research and development
$ 576,260
$ 552,126
$ 24,134
General and administrative
1,480,360
1,413,592
66,768
Total operating expenses
$ 2,056,620
$ 1,965,718
$ 90,902
Research
and Development
Our
research and development expenses for the three months ended March 31, 2025 increased, compared to the same period ended March 31, 2024,
primarily due to increased licensing costs and the expansion of our target discovery and validation efforts.
General
and Administrative
Our
general and administrative expenses for the three months ended March 31, 2025 increased, compared to the same period ended March 31,
2024, primarily due to increased personnel costs for employee hirings and fringe benefits.
Other
Income (Expense), Net
Interest
income earned on cash held in an overnight sweep account was approximately $40,000 for the three months ended March 31, 2025 as compared
to income of approximately $65,000 for the three months ended March 31, 2024. The decrease was primarily due to a decrease in our average
cash balance in our interest-bearing bank accounts.
Liquidity
and Capital Resources
Through
March 31, 2025, we have an accumulated deficit of approximately $18.8 million and have funded our operations primarily through the sale
of common stock, warrants and debt. We anticipate that our expenses will increase in the future to support our service offerings, clinical
and pre-clinical research and development activities associated with strategic partnering and collaborations, as well as acquired product
candidates. These increases could include increased costs related to the hiring of additional personnel and fees to outside consultants,
lawyers, and accountants, among other expenses.
18
In
February 2024, we completed an underwritten offering of common stock and warrants generating approximately $5.7 million of net proceeds.
In
October 2024, we completed a registered direct offering of common stock and pre-funded warrants, and concurrent private placement of
common stock warrants generating approximately $2.7 million of net proceeds.
As
of March 31, 2025, the Company’s cash and cash equivalents position is not sufficient to fund the Company’s planned operations
for at least a year beyond the filing date of the unaudited condensed consolidated financial statements. These factors raise substantial
doubt about the Company’s ability to continue as a going concern. The ability to continue as a going concern is dependent upon
the Company obtaining the necessary financing and/or revenues to meet its obligations arising from normal business operations when they
become due. Accordingly, we will seek additional capital to continue to execute our strategy as discussed above.
In
April 2025, the Company entered into an At-The-Market Sales Agreement with BTIG, LLC, pursuant to which the Company may offer and sell
shares of common stock, from time to time in its sole discretion, at the market price and having an aggregate offering price of up to
$20 million. The Company is not obligated to sell any shares, and BTIG is not required to sell any specific number or dollar amount of
shares of common stock. Accordingly, the Company will not receive any proceeds from such transaction until shares are actually sold by
BTIG. Subject to the Company’s request to sell shares, BTIG will use commercially reasonable efforts, consistent with its normal
trading and sales practices, to sell shares of common stock on the Company’s behalf in accordance with Company instructions. Notwithstanding
the foregoing, there can be no assurance that the Company will be able to sell, when needed, sufficient shares under the At-The-Market
Sales Agreement to fund planned operations.
Consolidated
Cash Flow Data
Three Months Ended March 31,
2025
2024
Change
Net cash (used in) provided by
Operating activities
$ (1,798,125 )
$ (1,901,634 )
$ 103,509
Investing activities
-
-
-
Financing activities
164,070
6,287,621
(6,123,551 )
Net (decrease) increase in cash and cash equivalents
$ (1,634,055 )
$ 4,385,987
$ (6,020,042 )
Cash
Flows Used in Operating Activities
Net
cash used in operating activities for the three months ended March 31, 2025 decreased compared to the same period ended March 31, 2024
primarily due to the decrease in our D&O insurance premium, partially offset by increased operating costs in 2025.
Cash
Flows Used in Investing Activities
There
was no cash used in investing activities during the three months ended March 31, 2025 or 2024.
Cash
Flows (Used in) Provided by Financing Activities
Net
cash provided by financing activities for the three months ended March 31, 2025 decreased compared to the same period ended March 31,
2024 primarily due to proceeds from our secondary offering in February 2024 and a reduction in our D&O insurance premium financing.
Item
3. Quantitative and Qualitative Disclosures about Market Risk
As
a smaller reporting company, this disclosure is not required.
19
Item
4. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
We
are required to maintain “disclosure controls and procedures” as such term is defined in Rule 13a-15(e) under the Securities
Exchange Act of 1934 (the “Exchange Act”). In designing and evaluating our disclosure controls and procedures, our management
recognized that disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute,
assurance that the objectives of disclosure controls and procedures are met. The design of any disclosure controls and procedures is
also based, in part, upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will
succeed in achieving its stated goals under all potential future conditions. We conducted an evaluation of the effectiveness of our disclosure
controls and procedures as of March 31, 2025. Based on this evaluation, our chief executive officer and chief financial officer concluded
that our disclosure controls and procedures were not effective as of the end of the reporting period covered in this Quarterly Report
on Form 10-Q as a result of the previously identified material weaknesses in our internal control over financial reporting described
below. Notwithstanding the identified material weaknesses, our management has concluded that the unaudited condensed consolidated financial
statements in this filing on Form 10-Q fairly present, in all material respects, our financial position, results of operations and cash
flows as of and for the periods presented in conformity with GAAP.
Material
Weakness and Ongoing Remediation Efforts
As
previously disclosed, management identified material weaknesses in its internal controls over financial reporting at December 31, 2023
which continue to be unremediated as of March 31, 2025. Specifically, management noted the Company did not properly document, implement
or operate a system of effective internal controls over financial reporting. A material weakness is a deficiency, or a combination of
deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement
of the company’s annual or interim financial statements will not be prevented or detected on a timely basis.
Management
is in the process of implementing improvements to its internal controls over financial reporting. Namely, the Company has and is continuing
to:
● transition
its day-to-day accounting processes to an external firm including automating its vendor payments;
● complete
the transfer of the overall accounting process to an enterprise type accounting platform;
● review
the design and effectiveness of our controls including the creation of an annual risk assessment
and ongoing monitoring activities;
● evaluate
all internal and external resources to ensure they are appropriate for the level and complexity
of our current operations;
● hired
a Corporate Controller in 2024; and
● engaged
a third-party specialist to assist in the remediation and ongoing evaluation of our internal
controls over financial reporting.
While
we believe that these efforts will improve our internal control over financial reporting, the implementation of these measures is ongoing
and will require validation and testing of the design and operating effectiveness of internal controls over a sustained period of financial
reporting cycles. We will continue to monitor and evaluate the effectiveness of our internal control over financial reporting on an ongoing
basis and are committed to taking further action and implementing additional enhancements or improvements, as necessary and as funds
allow. We cannot assure you that the measures we have taken to date, or that we may take in the future, will be sufficient to remediate
the material weaknesses we have identified or avoid potential future material weaknesses. Accordingly, there could continue to be a reasonable
possibility that a material misstatement of our financial statements would not be prevented or detected on a timely basis.
Changes
in Internal Control Over Financial Reporting
Other
than the material weakness remediation efforts described above, there has been no change in the Company’s internal control over
financial reporting during the Company’s most recent quarter that has materially affected, or is reasonably likely to materially
affect, the Company’s internal control over financial reporting.
20
PART
II. OTHER INFORMATION
Item 1 Legal Proceedings.
To
our best knowledge, we are currently not a party to any legal proceedings that, individually or in the aggregate, are deemed to be material
to our financial condition or results of operations.
Item 1A Risk Factors.
Smaller
reporting companies are not required to provide the information required by this item.
Item 2 Unregistered Sales of Equity Securities and Use of Proceeds.
There
were no unregistered sales of equity securities during the three months ended March 31, 2025.
Item 3 Defaults Upon Senior Securities.
None.
Item 4 Mine Safety Disclosures.
Not
applicable.
Item 5 Other Information.
(c)
Insider Trading Arrangements
During
the quarter ended March 31, 2025, none of the Company’s directors or executive officers adopted , modified or terminated any contract,
instruction or written plan for the purchase or sale of Company securities that was intended to satisfy the affirmative defense conditions
of Rule 10b5-1(c) or any “non-Rule 10b5-1 trading arrangement.” As previously disclosed, in June 2023 , Vininder Singh , the
Chief Executive Officer and a Director of the Company, entered into a 10b5-1 sales plan (the “10b-5 Sales Plan”) intended
to satisfy the affirmative defense of Rule 10b5-1(c) under the Exchange Act. The 10b5 Sales Plan provides for the sale of up to 1,000,000
shares of common stock and will remain in effect until the earlier of (1) August 31, 2025; or (2) the date on which an aggregate of 1,000,000
shares of common stock have been sold under the 10b5 Sales Plan. Pursuant to the 10b5 Sales Plan, 50,000 shares were sold under the plan
in September 2023, 100,000 shares were sold under the plan in the first quarter of 2024, and 50,000 shares were sold under the plan in
each of the second, third, and fourth quarters of 2024, and in the first quarter of 2025.
Item 6 Exhibits.
Exhibit
No.
Description
31.1
*
Certification of Chief Executive Officer pursuant to Rule 13a-14(a)/15d-14(a).
31.2
*
Certification of Chief Financial Officer pursuant to Rule 13a-14(a)/15d-14(a).
32.1
*
Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2
*
Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.INS
*
Inline
XBRL Instance Document.
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
The
cover page from the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, formatted in Inline XBRL
(included in Exhibit 101).
*
Filed herewith.
21
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed
on its behalf by the undersigned thereunto duly authorized.
Bullfrog
AI Holdings, Inc.
Date:
May 13, 2025
By:
/ s/
Vininder Singh
Vininder
Singh
Chief
Executive Officer
Date:
May 13, 2025
By:
/s/
Josh Blacher
Josh
Blacher
Chief
Financial Officer
22
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.