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 September 30, 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 November 12, 2025 was 11,409,745 .
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
18
Item 3.
Quantitative and Qualitative Disclosures About Market Risk
24
Item 4.
Controls and Procedures
24
PART II.
OTHER INFORMATION
26
Item 1.
Legal Proceedings
26
Item 1A.
Risk Factors
26
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
26
Item 3.
Defaults Upon Senior Securities
26
Item 4.
Mine Safety Disclosures
26
Item 5.
Other Information
27
Item 6.
Exhibits
27
SIGNATURES
28
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 largely based upon management’s
current expectations and beliefs about future events and trends affecting our business, which management believes are reasonable. These
forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those anticipated
in the forward-looking statements. 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)
September 30, 2025
December 31, 2024
Assets
Current assets
Cash and cash equivalents
$ 1,990,712
$ 5,435,983
Accounts receivable
58,335
-
Prepaid expenses and other assets
487,018
111,597
Total current assets
2,536,065
5,547,580
Restricted cash
105,000
-
Property and equipment, net
2,956
4,250
Investments
58,335
-
Total assets
$ 2,702,356
$ 5,551,830
Liabilities and Stockholders’ Equity
Current liabilities
Accounts payable
$ 168,212
$ 435,934
Accrued expenses
534,883
152,156
Short term insurance financing
55,606
-
Total current liabilities
758,701
588,090
Total liabilities
758,701
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 September 30, 2025 and December 31, 2024.
1
1
Common stock, $ 0.00001 par value, 100,000,000 shares authorized; 10,416,721 and 9,113,139 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively.
104
91
Additional paid-in capital
23,755,000
21,757,204
Accumulated deficit
( 21,811,450 )
( 16,793,556 )
Total stockholders’ equity
1,943,655
4,963,740
Total liabilities and stockholders’ equity
$ 2,702,356
$ 5,551,830
See
accompanying notes to unaudited condensed consolidated financial statements.
2
BullFrog
AI Holdings, Inc.
Condensed
Consolidated Statements of Operations
(Unaudited)
2025
2024
2025
2024
Three Months Ended
Nine Months Ended
September 30,
September 30,
2025
2024
2025
2024
Revenue
Collaboration revenue
$ 83,413
$ -
$ 116,670
$ -
Total revenue
83,413
-
116,670
-
Cost of revenue
Cost of collaboration revenue
68,043
-
94,778
-
Total cost of revenue
68,043
-
94,778
-
Gross profit
15,370
-
21,892
-
Operating expenses
Research and development
345,992
566,584
1,402,549
1,632,409
General and administrative
1,239,061
1,253,357
3,715,319
3,835,213
Total operating expenses
1,585,053
1,819,941
5,117,868
5,467,622
Loss from operations
( 1,569,683 )
( 1,819,941 )
( 5,095,976 )
( 5,467,622 )
Other income (expense), net
Interest expense, net
( 1,543 )
( 4,978 )
( 5,007 )
( 16,150 )
Interest income
19,614
61,455
83,089
204,868
Total other income (expense), net
18,071
56,477
78,082
188,718
Net loss
( 1,551,612 )
( 1,763,464 )
( 5,017,894 )
( 5,278,904 )
Deemed dividend related to warrant exercise price adjustment
-
-
-
( 16,774 )
Net loss attributable to common stockholders
$ ( 1,551,612 )
$ ( 1,763,464 )
$ ( 5,017,894 )
$ ( 5,295,678 )
Net loss per common share attributable to common stockholders - basic and diluted
$ ( 0.15 )
$ ( 0.22 )
$ ( 0.51 )
$ ( 0.67 )
Weighted average number of shares outstanding - basic and diluted
10,379,775
8,124,834
9,927,842
7,880,288
See
accompanying notes to unaudited condensed consolidated financial statements.
3
BullFrog
AI Holdings, Inc.
Condensed
Consolidated Statements of Changes in Stockholders’ Equity
(Unaudited)
Shares
Amount
Shares
Amount
in Capital
Deficit
Equity
Series A Preferred Stock
Common Stock
Additional Paid-
Accumulated
Total Stockholders’
Shares
Amount
Shares
Amount
in 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
Stock-based compensation
-
-
-
-
192,382
-
192,382
Net loss
-
-
-
-
-
( 1,611,646 )
( 1,611,646 )
Balance at June 30, 2024
73,449
1
7,850,550
79
18,672,120
( 13,287,138 )
5,385,062
Stock-based compensation
-
-
-
-
201,571
-
201,571
Net loss
-
-
-
-
-
( 1,763,464 )
( 1,763,464 )
Balance at September 30, 2024
73,449
$ 1
7,850,550
$ 79
$ 18,873,691
$ ( 15,050,602 )
$ 3,823,169
Balance at December 31, 2024
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
Stock-based compensation
-
-
-
-
177,905
-
177,905
Issuance of common stock, net of issuance costs
-
-
211,589
2
212,457
-
212,459
Net loss
-
-
-
-
-
( 1,448,729 )
( 1,448,729 )
Balance at June 30, 2025
73,449
1
9,627,114
96
22,447,851
( 20,259,838 )
2,188,110
Balance
73,449
1
9,627,114
96
22,447,851
( 20,259,838 )
2,188,110
Stock-based compensation
-
-
-
-
378,230
-
378,230
Issuance of common stock, net of issuance costs
-
-
481,898
5
721,429
-
721,434
Issuance of common stock pursuant to equity incentive plan
-
-
160,027
2
( 2 )
-
-
Issuance of common stock as commitment fee in advance of equity transaction
-
-
147,682
1
207,492
-
207,493
Net loss
-
-
-
-
-
( 1,551,612 )
( 1,551,612 )
Balance at September 30, 2025
73,449
$ 1
10,416,721
$ 104
$ 23,755,000
$ ( 21,811,450 )
$ 1,943,655
Balance
73,449
$ 1
10,416,721
$ 104
$ 23,755,000
$ ( 21,811,450 )
$ 1,943,655
See
accompanying notes to unaudited condensed consolidated financial statements.
4
BullFrog
AI Holdings, Inc.
Condensed
Consolidated Statements of Cash Flows
(Unaudited)
2025
2024
Nine Months Ended September 30,
2025
2024
Cash flows from operating activities:
Net loss
$ ( 5,017,894 )
$ ( 5,278,904 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation
1,294
1,293
Stock-based compensation
856,423
729,370
Changes in operating assets and liabilities:
Accounts receivable
( 58,335 )
-
Prepaid expenses and other assets
( 167,928 )
( 212,655 )
Investments
( 58,335 )
-
Accounts payable
( 267,722 )
( 12,282 )
Accrued expenses
375,227
434,964
Net cash used in operating activities
( 4,337,270 )
( 4,338,214 )
Cash flows from investing activities:
Net cash used in investing activities
-
-
Cash flows from financing activities:
Proceeds from sale of common stock from ATM, net of issuance costs
941,393
-
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
( 126,191 )
( 389,880 )
Net cash provided by financing activities
996,999
5,952,472
Net (decrease) increase in cash and cash equivalents
( 3,340,271 )
1,614,258
Cash and cash equivalents, beginning of period
5,435,983
2,624,730
Cash and cash equivalents, end of period
$ 2,095,712
$ 4,238,988
Supplemental cash flow information:
Cash paid for interest
$ 5,007
$ 16,150
Cash paid for taxes
$ -
$ -
Supplemental disclosures of noncash investing and financing activities
Issuance of common stock as commitment fee in advance of equity transaction
$ 207,493
$ -
See
accompanying notes to 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 have emerged as a digital solution to help address this problem.
The
Company uses AI/ML to advance medicines for both internal and external projects. Currently, most 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,
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 can 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 continues its internal efforts related to target discovery.
The
Company’s goal is to improve the odds of success at all stages of pre-clinical and clinical 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.
6
Liquidity
and Going Concern
The
Company has generated negative cash flows from operations and operated at a net loss since inception. As of September 30, 2025, the Company
has a cash balance of approximately $ 2.1 million, which includes restricted cash of $ 0.1 million held by a financial institution as collateral
for the Company’s corporate credit card program. 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. During the three months ended June 30, 2025
and September 30, 2025, the Company received net proceeds of approximately $ 0.3 million and $ 0.7 million, respectively, from the sale
of its common stock pursuant to the Company’s At-The-Market Sales Agreement with BTIG, LLC (the “ATM Agreement”). As
of September 30, 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. This risk factor, as well as
other 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,
the Company will require additional capital to continue to execute its strategy. The Company anticipates securing this additional
capital through various avenues including revenues from licensing agreements and collaborative arrangements within its operating business
and/or the selling of equity securities or entry into debt transactions. Although management believes that such funding sources will
be available, including pursuant to the Company’s at-the-market common stock sales facility provided by our ATM Agreement and pursuant
to the Company’s equity line of credit facility provided by our purchase agreement with Lincoln Park Capital Fund, LLC, there can
be no assurance that any such arrangements will 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 capital expenditures
or enter into arrangements on unfavorable terms. The Company currently does not have commitments for future funding from any source other
than those noted above. Furthermore, the issuance of additional equity securities may be significantly dilutive to the Company’s
current shareholders.
On
August 21, 2025, the Company received a letter from the listing staff of The Nasdaq Stock Market LLC (“Nasdaq”) that the
Company was no longer in compliance with the minimum stockholders’ equity requirement for continued listing on Nasdaq pursuant
to Nasdaq Listing Rule 5550(b)(1) (the “Stockholders’ Equity Rule”). The Stockholders’ Equity Rule requires companies
listed on the Nasdaq Capital Market to maintain stockholders’ equity of at least $ 2,500,000 or to meet alternatives of market value
of listed securities or net income from continuing operations, which the Company does not currently meet. In accordance with Nasdaq rules,
the Company had 45 calendar days, or until October 6, 2025, to submit a plan to regain compliance. After submitting the plan to regain
compliance, on October 7, 2025, Nasdaq granted the Company an extension until February 17, 2026, to comply with Listing Rule 5550(b)(1).
The Company is taking steps in accordance with its plan to regain and evidence compliance with the Stockholders’ Equity Rule or
meet the alternative compliance standards, but there can be no assurance that the Company will regain compliance.
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 its Annual Report on Form 10-K for the fiscal year ended December 31, 2024 have not materially changed during
the nine months ended September 30, 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.
7
The
results for the nine months ended September 30, 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.
The
CODM assesses Company performance through the achievement of revenue, cost optimization, and 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.
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 or 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 or 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 that may be recognized 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 through
collaboration agreements with companies such as BullFrog. A secondary revenue channel is fee-for-service partnerships and collaborations
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 related to such agreements in either cash, the equity of its partners, 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.
8
Investments
The
Company currently has a single investment in equity securities issued by a privately held entity. The Company entered into a strategic
collaboration agreement and received such equity securities as remuneration for services rendered. The Company has elected to account
for this investment using the measurement alternative as the investment does not have a readily determinable fair value. Pursuant to
this alternative, the investment will be carried at its estimated fair value calculated as its cost minus any impairment. The Company
will adjust the investment to fair value only when it identifies observable price changes in orderly transactions for identical or similar
investments of the same issuer. The Company will evaluate the investment at each reporting period to determine whether the investment
is impaired.
Financial
Instruments
The
carrying value of short-term instruments, including cash and cash equivalents, accounts payable and accrued expenses approximate fair
value due to the relatively short period to maturity for these instruments. The Company has elected to account for its single investment
using the measurement alternative and it is considered a financial instrument accounted for at fair value on a non-recurring basis. Fair
value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal
or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date.
Valuation techniques used to measure fair value maximize the use of observable inputs and minimize the use of unobservable inputs. The
Company utilizes a three-level valuation hierarchy for disclosures of fair value measurements, defined as follows:
Level
1 - inputs to the valuation methodology are quoted prices (unadjusted) for identical assets or liabilities in active markets.
Level
2 - inputs to the valuation methodology include quoted prices for similar assets and liabilities in active markets, and inputs that are
observable for the assets or liabilities, either directly or indirectly, for substantially the full term of the financial instruments.
Level
3 - inputs to the valuation methodology are unobservable and significant to the fair value. The Company does not have any assets or liabilities
that are required to be measured and recorded at fair value on a recurring basis.
Recent
Accounting Pronouncements
In
December 2023, the FASB issued ASU No. 2023-09 which 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 is in the process of evaluating the effects of this guidance on its condensed consolidated
financial statements.
In
July 2025, the FASB issued ASU No. 2025-05 which amends Topic 326. Specifically, the ASU provides a practical expedient whereby an entity
can assume that current conditions as of the balance sheet date will not change for the remaining life of the asset (e.g., the accounts
receivable). This guidance is effective for the Company’s fiscal year ending December 31, 2026 and can be adopted early. The Company
is in the process of evaluating the effects of this guidance on its condensed consolidated financial statements.
In
September 2025, the FASB issued ASU No. 2025-07 which, among other things, provides scope clarification for share-based noncash consideration
from a customer in a revenue contract. Specifically, the ASU clarifies that share-based payments from customers in exchange for the transfer
of goods or services should be accounted for as noncash consideration within the scope of ASC 606 as opposed to as a derivative pursuant
to ASC 815 or as an equity security pursuant to ASC 321. This guidance is effective for the Company’s fiscal year ending December
31, 2027 and can be adopted early. The Company is in the process of evaluating the effects of this guidance on its condensed consolidated
financial statements.
9
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. Investments
The
Company’s sole investment is in the form of equity securities in a private entity. The Company entered into a strategic collaboration
agreement and received such equity securities as remuneration for services rendered. The investment is initially valued at approximately
$ 58,000 (see Note 4). The Company has elected the measurement alternative and, accordingly, it is carried at its estimated fair value
calculated as its cost less any impairment charges until such time as there is evidence of an orderly transaction (see Note 2). As of
September 30, 2025, no fair value adjustments have been recognized, nor have there been any impairment charges. This investment is considered
a financial asset that is measured at fair value on a non-recurring basis.
4. Revenue
The
Company had an agreement with a single customer, Eleison Pharmaceuticals, Inc. (“Eleison”), for contract services. The collaboration
agreement, which was entered into in February 2025 and designed to enhance clinical trial efficiency, extract actionable insights from
historical and ongoing data and improve strategic planning for Eleison’s oncology pipeline, was deemed to have multiple deliverables
with revenue to be recognized at the time each deliverable was completed. In exchange for the services provided, the Company is entitled
to consideration in the form of cash or equity securities of the customer or any combination at the customer’s sole discretion.
The Company received the initial payment in the second quarter of 2025, representing 50% of the total consideration, in the form of equity
securities of the customer (see Note 3) valued at approximately $ 58,000 , and the remaining consideration, also valued at approximately
$ 58,000 , was due upon completion of the final deliverable. The Company allocated the total proceeds to each of the separate deliverables
on a relative basis based on the estimated stand-alone selling price of each deliverable. All deliverables were completed in the nine
months ended September 30, 2025 and, consequently, the Company recognized approximately $ 117,000 of revenue at the point in time that
each deliverable was completed.
In
June 2025, the Company entered into a strategic collaboration with Sygnature Discovery (“Sygnature”), a UK-based contract
research organization specializing in drug discovery. Under this collaboration, Sygnature will introduce BullFrog Data Networks™,
the Company’s proprietary AI-driven data insights platform powered by the bfLEAP™ engine, to Sygnature’s global biopharma
client base. Any commercial terms for the marketing collaboration will be agreed by the parties in a subsequent agreement. The Company has not yet recognized any revenue under this collaboration.
The
Company currently has no other revenue agreements. Additionally, the Company has no contract assets or contract costs at September 30,
2025.
5. Notes
Payable
In
February 2025, the Company entered into an agreement to finance a portion of the premium for its directors and officers insurance policy
for the policy period of February 2025 through February 2026. The agreement provides for financing of $ 181,797 of the premium, which
financing will be repaid in 10 equal monthly installments of $ 18,743 each through December 2025 and accrues interest at 6.70 %.
6. 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
September 30, 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.
10
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 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 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 $ 3.1 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 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. The pre-funded warrants
were exercised in their entirety in cashless exercise transactions as of March 31, 2025, pursuant to which 702,373 shares of common stock
were issued.
In
April 2025, the Company entered into 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 $ 20.0 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
and will reimburse BTIG for reasonable and documented out-of-pocket expenses incurred by BTIG, including the reasonable and documented
fees and disbursements of counsel to BTIG, subject to specified caps.
Through
September 30, 2025, the Company received approximately $ 1.1 million of gross proceeds from the sale of 693,487 shares of the Company’s
common stock at an average price of approximately $ 1.58 per share. In connection with these sales, the Company incurred expenses of approximately
$ 164,000 , of which $ 7,500 remains unpaid at September 30, 2025. As of September 30, 2025, approximately $ 18.9 million of capacity remains
available under the ATM Agreement; however, the amount the Company is permitted to raise in any 12-month period is limited based on its
public float pursuant to SEC General Instruction I.B.6 of Form S-3. Accordingly, as of September 30, 2025, the Company is limited to
additional common stock sales of approximately $ 2.0 million. This amount is subject to adjustment based on increases in the Company’s
public float.
11
In
September 2025, the Company entered into a purchase agreement with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant
to which Lincoln Park committed to purchase up to $ 10.0 million of the Company’s common stock, subject to certain limitations.
The Company has the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase up to $ 10.0 million
of the Company’s common stock. Such sales of common stock by the Company, if any, will be subject to certain limitations set forth
in the purchase agreement, and may occur from time to time, at the Company’s sole discretion, over the 36-month period commencing
on the date that the conditions to Lincoln Park’s purchase obligation set forth in the purchase agreement are satisfied, including
that a registration statement covering the resale by Lincoln Park of shares of common stock that have been and may be issued to Lincoln
Park under the purchase agreement, which the Company filed with the SEC in October 2025, is declared effective by the SEC. No shares
were sold under this facility during the nine months ended September 30, 2025. In connection with this agreement, the Company issued
147,682 shares of common stock valued at approximately $ 207,000 to Lincoln Park as a fee in advance of any sales pursuant to this facility.
Dilutive
securities are excluded from the diluted earnings per share calculation because their effect is anti-dilutive. As of September 30, 2025,
73,449 shares of preferred stock, 6,940,042 warrants, 866,412 options for shares of common stock, and 342,030 unvested RSUs were excluded
from the calculation of net loss per share. As of September 30, 2024, 73,449 shares of preferred stock, 5,307,444 warrants and 849,427
options for shares of common stock were excluded from the calculation of net loss per share. For
each of the three- and nine-month periods ended September 30, 2025 and September 30, 2024, 274,286 pre-funded warrants issued
in 2020 as consideration for services were included in the calculation of net loss per common share.
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 September 30, 2025, there are 14,348 awards authorized but unissued available under the Plan. In
October 2025, the Company’s stockholders approved an amendment to the Plan to increase the number of shares available for issuance
under the Plan by 750,000 .
Stock
Options
The
following tables summarize the stock option activity for the nine months ended September 30, 2025 and 2024:
Schedule of Stock Options Activity
Number of
Shares
Weighted-
Average
Exercise Price
Weighted-
Average
Remaining Contractual
Term (Years)
Aggregate
Instrinsic Value
Oustanding at December 31, 2024
832,731
$ 3.96
8.5
$ -
Granted
256,500
$ 2.12
Exercised
-
$ -
Forfeited / canceled
( 222,819 )
$ 3.71
Outstanding at September 30, 2025
866,412
$ 3.51
8.4
$ -
Vested at September 30, 2025
601,520
$ 3.98
8.1
$ -
12
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
368,000
$ 3.71
Exercised
-
$ -
Forfeited / canceled
( 46,290 )
$ 3.95
Outstanding at September 30, 2024
849,427
$ 3.98
8.7
$ 25,652
Vested at September 30, 2024
449,434
$ 4.06
8.3
$ 16,837
The
fair value of options granted during the nine months ended September 30, 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
Nine Months Ended September 30,
2025
2024
Expected dividend yield
0 %
0 %
Expected volatility
94 % - 97 %
92 % - 97 %
Risk-free interest rate
3.8 % - 4.5 %
3.5 % - 4.4 %
Expected life (in years)
5.5
5.3 - 6.0
● Dividend
yield – The Company does not expect to pay a dividend in the foreseeable future.
● Volatility
– The trading volatility was determined by calculating the volatility of the Company’s
peer group.
● Risk-free
interest rate – This is the U.S. Treasury rate, having a term comparable to the
expected life of the stock option.
● Expected
life of options – The expected life of options granted to employees was determined
using the simplified method.
The
weighted-average grant-date fair value of options granted during the nine months ended September 30, 2025 and 2024 was $ 1.57 and $ 2.83 ,
respectively.
During
the three and nine months ended September 30, 2025, the Company recognized $ 145,388 and $ 623,581 , respectively, of compensation expense
related to stock options. During the three and nine months ended September 30, 2024, the Company recognized $ 201,571 and $ 726,363 , respectively,
of compensation expense related to stock options.
As
of September 30, 2025, the total unrecognized compensation expense related to unvested stock options was approximately $ 253,000 , which
the Company expects to recognize over a weighted-average period of approximately 1.3 years.
Restricted
Stock Units
During
the three months ended September 30, 2025, the Company granted 342,030 restricted stock units (“RSUs”) with an average grant
date fair value of $ 1.27 . The RSUs vest over a two-year 2 period. During the three and nine months ended September 30, 2025, the Company
recognized $ 18,099 of compensation expense related to RSUs.
As
of September 30, 2025, the total unrecognized compensation expense related to unvested RSUs was approximately $ 416,000 , which the Company
expects to recognize over a weighted-average period of approximately 1.9 years.
13
Stock
Grants
During
the three months ended September 30, 2025, the Company granted 168,465 shares of common stock with an average grant date fair value of
$ 1.27 , all of which were fully vested at the grant date. Of the 168,465 shares granted, 8,438 were not legally issued as of September
30, 2025. During the three and nine months ended September 30, 2025, the Company recognized $ 213,951 of compensation expense related
to the stock grants.
Warrants
The
following table provides details for the Company’s outstanding warrants as of September 30, 2025:
Schedule
of Outstanding Warrants
Exercise Price
Expiration
Number of Warrants
$ 0.0007
2030
274,286
$ 1.22
2036
5,000
$ 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
7,214,328
Warrants
Issued in Conjunction with Transactions
During
the year ended December 31, 2024, the Company issued the following warrants as part of two secondary
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 September 30, 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 initial public offering
(“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 September 30, 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
September 30, 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. The
pre-funded warrants were exercised in their entirety in cashless exercise transactions as
of March 31, 2025, pursuant to which 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 September 30, 2025, none of these warrants have been exercised.
14
Warrants
Issued as Consideration for Services
The
following table summarizes the activity for warrants issued as consideration for services for the nine months ended September 30, 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
5,000
$ 1.22
Exercised
-
$ -
Forfeited / canceled
-
$ -
Outstanding at September 30, 2025
668,891
$ 1.54
4.9
$ 384,708
Vested at September 30, 2025
664,724
$ 1.55
4.9
$ 383,958
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 September 30, 2024
663,891
$ 1.55
5.8
$ 964,513
Vested at September 30, 2024
663,891
$ 1.55
5.8
$ 964,513
During
the three and nine months ended September 30, 2025, the Company recognized $ 792 of compensation expense related to certain warrants.
During the three and nine months ended September 30, 2024, the Company recognized $ 0 and $ 3,007 , respectively, of compensation expense
related to certain warrants.
As
of September 30, 2025, there was $ 3,958 of unrecognized compensation expense related to unvested warrants.
7. Income
Taxes
The
Company has not recorded any tax provision or benefit for the nine months ended September 30, 2025 and 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 September 30, 2025 and December 31, 2024.
8. 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 IPO and subsequent financings.
15
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, the second of these payments for $ 75,000 was paid in June 2025, and the remaining payments
of $ 75,000 and $ 50,000 are due in 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 September 30, 2025, all minimum annual royalty payments through 2024 have been paid, the Company has accrued $ 225,000 of the $ 300,000
minimum annual royalty due in December 2025, and the Company has accrued $ 25,000 of the $ 75,000 annual license fee due in June 2026.
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 fees 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 September 30, 2025, there has been no accrual for royalties since
the Company has not begun to generate applicable revenue; however, the Company has accrued $ 15,000 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.
16
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).
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 September 30, 2025, the Company has accrued $ 22,500 of the $ 30,000 annual minimum royalty 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 – 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 September 30, 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.
Lieber
Institute for Brain Development Partnership
In
September 2023, the Company entered into a Data Use and Technology Partnership Agreement (the “Data Use Agreement”) and a
related Memorandum of Understanding (“MOU”) with the Lieber Institute for Brain Development (“LIBD”), a nonprofit
medical research organization focused on mental health disorders. The partnership is intended to combine LIBD’s proprietary brain-related
datasets with the Company’s artificial intelligence and machine learning capabilities to support drug discovery and development
activities.
Under
the Data Use Agreement, LIBD granted the Company a limited, royalty-free, non-transferable license to access and use certain curated
LIBD datasets solely for the application of artificial intelligence and machine learning to drug development, excluding diagnostic uses.
The license was exclusive for an initial one-year term beginning upon receipt of the first significant tranche of data and was subsequently
extended. The Company is responsible for all costs associated with the development plan and is required to provide LIBD with the resulting
deliverables upon completion of the exclusivity period.
The
MOU outlines key terms for a future commercial agreement governing the potential commercialization of products or services derived from
LIBD data. Under the proposed structure, LIBD would receive royalties on net sales and a percentage of sublicense revenue, with rates
varying based on the source of commercialization. The Company has also agreed to provide LIBD with any such products or services free
of charge for LIBD’s internal research use.
9. 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 9 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.
Subsequent
to the quarter ended September 30, 2025, the Company continued to raise capital through sales of shares of its common stock under its
ATM Agreement. Subsequent to September 30, 2025, the Company raised gross proceeds of approximately $ 1.6 million, before deducting commissions
and offering expenses, through sales of shares of its common stock pursuant to the ATM Agreement.
17
Item 2. Management’s
Discussion and Analysis of Financial Condition 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 to 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 for $75,000 was paid in July 2023, the second of these payments
for $75,000 was paid in June 2025, and the remaining payments of $75,000 and $50,000 are due in 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 are $30,000 for 2022, $60,000 for 2023, and $300,000 for 2024 and beyond, all of which are creditable against
royalties paid by us. As of September 30, 2025, all minimum annual royalty payments through 2024 have been paid, the Company has accrued
$225,000 of the $300,000 minimum annual royalty due in December 2025, and the Company has accrued $25,000 of the $75,000 annual license
fee due in June 2026.
18
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.
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, 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, and completed our collaboration agreement for clinical trial optimization with a Phase III oncology
company focused on novel chemotherapeutic treatments for rare cancers in the third quarter of 2025. 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 and our ongoing At-The-Market Sales Agreement with BTIG, LLC (the “ATM
Agreement”), 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, 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 and consultants 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 LIBD. We are also continuing to
improve 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.
19
The
Company has incurred 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. 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. Through September 30, 2025, we received
approximately $1.1 million of net proceeds from the sale of our common stock pursuant to the ATM Agreement. As of September 30, 2025,
the Company has a cash balance of approximately $2.1 million, which includes $0.1 million of restricted cash held by a financial institution
as collateral for the Company’s corporate credit card program. As of September 30, 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. This risk factor, as well as other 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 securing this additional capital through various
avenues including revenues from licensing agreements and collaborative arrangements within our operating business and/or the selling
of equity securities or entry into debt transactions. Although management believes that such funding sources will be available, including
pursuant to the Company’s at-the-market common stock sales facility under our ATM Agreement and pursuant to our equity line of
credit facility provided by our purchase agreement with Lincoln Park Capital Fund, LLC, there can be no assurance that any such arrangements
will 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 capital expenditures or enter into arrangements on unfavorable terms. We currently
do not have commitments for future funding from any source other than those noted above. Furthermore, the issuance of additional equity
securities may be significantly dilutive to our current shareholders.
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 in our partners, 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 in the third quarter of 2023 and recognized revenue in the amount of $65,000. We did
not recognize any revenue in 2024. In February 2025, we entered into a collaboration agreement with Eleison Pharmaceuticals Inc. (“Eleison”),
a Phase III oncology company focused on novel chemotherapeutic treatments for rare cancers, and we recognized approximately $83,000 and
$117,000, respectively, of revenue in the three and nine months ended September 30, 2025 pursuant to this agreement. Additionally, in
June 2025, we entered into a strategic collaboration agreement with Sygnature Discovery (“Sygnature”), pursuant to which
we established a joint marketing arrangement where Sygnature will introduce our BullFrog Data Networks™ platform to Sygnature’s
global biopharma client base; however, we have not yet recognized any revenue under this collaboration. We are in discussions with other
potential partners, although there can be no assurance of entering into other business relationships in 2025 or beyond.
20
Cost
of Revenue
Cost
of revenue consists primarily of the allocation of personnel costs (e.g. payroll, benefits, and consulting fees) of our employees and
third-party consultants directly attributable to the satisfaction of our performance obligations under our revenue arrangements.
Research
and Development Costs and Expenses
Research
and development costs and expenses include development activities related to 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 over time 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 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 September 30, 2025 and 2024
Collaboration
Revenue and Cost of Collaboration Revenue
We
recognized revenue and cost of revenue of approximately $83,000 and $68,000, respectively, for the three months ended September 30, 2025,
entirely related to our lone collaboration agreement with Eleison. The revenue and cost are for the completion of the final two deliverables
under the collaboration agreement. We had no active customer agreements in the comparable prior year period.
September 30,
Net Change
2025
2024
Operating expenses:
Research and development
$ 345,992
$ 566,584
$ (220,592 )
General and administrative
1,239,061
1,253,357
(14,296 )
Total operating expenses
$ 1,585,053
$ 1,819,941
$ (234,888 )
21
Research
and Development
Our
research and development expenses for the three months ended September 30, 2025 decreased, compared to the same period ended September
30, 2024, primarily due to a reduction in personnel costs and the allocation of certain personnel costs from research and development
to cost of revenue related to our collaboration with Eleison.
General
and Administrative
Our
general and administrative expenses for the three months ended September 30, 2025 decreased, compared to the same period ended September
30, 2024, primarily due to reductions in our director and officer insurance policy premium and recruiting fees, partially offset by an
increase in noncash stock-based compensation expense.
Other
Income (Expense), Net
Interest
income earned on cash held in an overnight sweep account was approximately $20,000 for the three months ended September 30, 2025 as compared
to approximately $61,000 for the three months ended September 30, 2024. The decrease was primarily due to a decrease in our average cash
balance.
Results
of Operations – Comparison of Nine Months Ended September 30, 2025 and 2024
Collaboration
Revenue and Cost of Collaboration Revenue
We
recognized revenue and cost of revenue of approximately $117,000 and $95,000, respectively, for the nine months ended September 30, 2025,
entirely related to our lone collaboration agreement with Eleison. The revenue and cost are for the completion of all deliverables under
the collaboration agreement. We had no active customer agreements in the comparable prior year period.
September 30,
Net Change
2025
2024
Operating expenses:
Research and development
$ 1,402,549
$ 1,632,409
$ (229,860 )
General and administrative
3,715,319
3,835,213
(119,894 )
Total operating expenses
$ 5,117,868
$ 5,467,622
$ (349,754 )
Research
and Development
Our
research and development expenses for the nine months ended September 30, 2025 decreased, compared to the same period ended September
30, 2024, primarily due to a reduction in personnel costs and the allocation of certain personnel costs from research and development
to cost of revenue related to our collaboration with Eleison, partially offset by an increase in licensing fees.
General
and Administrative
Our
general and administrative expenses for the nine months ended September 30, 2025 decreased, compared to the same period ended September
30, 2024, primarily due to reductions in our director and officer insurance policy premium and recruiting fees, partially offset by increases
in personnel costs and noncash stock-based compensation expense.
Other
Income (Expense), Net
Interest
income earned on cash held in an overnight sweep account was approximately $83,000 for the nine months ended September 30, 2025 as compared
to approximately $205,000 for the nine months ended September 30, 2024. The decrease was primarily due to a decrease in our average cash
balance.
22
Liquidity
and Capital Resources
Through
September 30, 2025, we have an accumulated deficit of approximately $21.8 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 partnerships 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.
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.
In
April 2025, the Company entered into an ATM 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 up to an aggregate offering price of $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 ATM Agreement to fund planned operations.
In the nine months ended September 30, 2025, the Company received approximately $1.1 million of net proceeds from the sale of 693,487
shares of the Company’s common stock at an average price of approximately $1.58 per share.
In
September 2025, the Company entered into a purchase agreement with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant
to which Lincoln Park committed to purchase up to $10.0 million of the Company’s common stock, subject to certain limitations.
The Company has the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase up to $10.0 million
of the Company’s common stock. Such sales of common stock by the Company, if any, will be subject to certain limitations set forth
in the purchase agreement, and may occur from time to time, at the Company’s sole discretion, over the 36-month period commencing
on the date that the conditions to Lincoln Park’s purchase obligation set forth in the purchase agreement are satisfied, including
that a registration statement covering the resale by Lincoln Park of shares of common stock that have been and may be issued to Lincoln
Park under the purchase agreement, which the Company filed with the U.S. Securities and Exchange Commission (the “SEC”) in
October 2025, is declared effective by the SEC. No shares were sold under this facility during the nine months ended September 30, 2025.
In connection with the purchase agreement, we issued 147,682 shares of common stock valued at approximately $207,000 to Lincoln Park
as a fee in advance of any sales pursuant to this facility.
As
of September 30, 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. This risk factor, as well as
other 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 seek additional capital to continue to execute our strategy as discussed
above.
On
August 21, 2025, the Company received a letter from the listing staff of The Nasdaq Stock Market LLC (“Nasdaq”) that the
Company was no longer in compliance with the minimum stockholders’ equity requirement for continued listing on Nasdaq pursuant
to Nasdaq Listing Rule 5550(b)(1) (the “Stockholders’ Equity Rule”). The Stockholders’ Equity Rule requires companies
listed on the Nasdaq Capital Market to maintain stockholders’ equity of at least $2,500,000 or to meet alternatives of market value
of listed securities or net income from continuing operations, which the Company does not currently meet. In accordance with Nasdaq rules,
the Company had 45 calendar days, or until October 6, 2025, to submit a plan to regain compliance. After submitting the plan to regain
compliance, on October 7, 2025, Nasdaq granted the Company an extension until February 17, 2026, to comply with Listing Rule 5550(b)(1).
The Company is taking steps in accordance with its plan to regain and evidence compliance with the Stockholders’ Equity Rule or
meet the alternative compliance standards, but there can be no assurance that the Company will regain compliance.
23
Consolidated
Cash Flow Data
Nine Months Ended September 30,
2025
2024
Change
Net cash (used in) provided by
Operating activities
$ (4,337,270 )
$ (4,338,214 )
$ 944
Investing activities
-
-
-
Financing activities
996,999
5,952,472
(4,955,473 )
Net (decrease) increase in cash and cash equivalents
$ (3,340,271 )
$ 1,614,258
$ (4,954,529 )
Cash
Flows Used in Operating Activities
Net
cash used in operating activities for the nine months ended September 30, 2025 was materially unchanged compared to the same period ended
September 30, 2024 primarily due to the reduction in our prepaid director and officer insurance policy premium offset by payments of
vendor payables.
Cash
Flows Used in Investing Activities
There
was no cash used in investing activities during the nine months ended September 30, 2025 or 2024.
Cash
Flows Provided by Financing Activities
Net
cash provided by financing activities for the nine months ended September 30, 2025 decreased compared to the same period of 2024 primarily
due to proceeds from our secondary offering and warrant exercises in 2024 along with a reduction in our director and officer insurance
policy premium financing partially offset by proceeds from sales of common stock under our ATM Agreement.
Item 3.
Quantitative and Qualitative Disclosures about Market Risk
As
a smaller reporting company, this disclosure is not required.
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 September 30, 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.
24
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 September 30, 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 a 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 controls 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.
25
PART
II. OTHER INFORMATION
Item 1 Legal
Proceedings.
To
the best of our knowledge, we are not currently 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.
Except
as set forth below, there have been no material changes to the Risk Factors disclosed in Part I, Item 1A, Risk Factors , of the
Company’s 2024 Form 10-K.
We
are currently listed on the Nasdaq Capital Market. If we are unable to maintain listing of our securities on Nasdaq or any stock exchange,
our stock price could be adversely affected and the liquidity of our stock and our ability to obtain financing could be impaired and
it may be more difficult for our shareholders to sell their securities.
Although
our common stock is currently listed on the Nasdaq Capital Market, we may not be able to continue to meet the exchange’s minimum
listing requirements or those of any other national exchange. The listing rules of Nasdaq require listing issuers to comply with certain
standards in order to remain listed on its exchange. For instance, on August 21, 2025, we received a letter from the listing staff of
The Nasdaq Stock Market LLC (“Nasdaq”) that the Company was no longer in compliance with the minimum stockholders’
equity requirement for continued listing on Nasdaq pursuant to Nasdaq Listing Rule 5550(b)(1) (the “Stockholders’ Equity
Rule”). The Stockholders’ Equity Rule requires companies listed on the Nasdaq Capital Market to maintain stockholders’
equity of at least $2,500,000 or to meet alternatives of market value of listed securities or net income from continuing operations,
which the Company does not currently meet. In accordance with Nasdaq rules, the Company had 45 calendar days, or until October 6, 2025,
to submit a plan to regain compliance. After submitting the plan to regain compliance, on October 7, 2025, Nasdaq granted the Company
an extension until February 17, 2026, to comply with Listing Rule 5550(b)(1). Although the Company is pursuing its compliance plan, there
can be no assurance that the Company will regain compliance.
If,
for any reason, we are unable to regain compliance with the Stockholders’ Equity Rule or we otherwise fail to maintain compliance
with Nasdaq’s listing standards, our securities would be subject to delisting by Nasdaq. In such case, unless we are able to list
on another national securities exchange, a reduction in some or all of the following may occur, each of which could have a material adverse
effect on our shareholders:
● the
liquidity of our common stock;
● the
market price of our common stock;
● our
ability to obtain financing for the continuation of our operations;
● the
number of investors that could consider investing in our common stock;
● the
number of market makers in our common stock;
● the
availability of information concerning the trading prices and volume of our common stock; and
● the
number of broker-dealers willing to execute trades in shares of our common stock.
Item
2 Unregistered
Sales of Equity Securities and Use of Proceeds.
Other
than as previously reported in the Company’s Current Reports on Form 8-K, there were no unregistered sales of equity securities
during the three months ended September 30, 2025.
Item
3 Defaults
Upon Senior Securities.
None.
Item
4 Mine
Safety Disclosures.
Not
applicable.
26
Item
5 Other
Information.
(c)
Insider Trading Arrangements
During
the quarter ended September 30, 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” other than the contractual expiration of the lone
10b5 Sales Plan (defined below). 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 “10b5 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 each of the first, second, and third quarters of 2025.
Item
6 EXHIBITS.
Exhibit
No.
Description
3.1
Amendment to the Bylaws of BullFrog AI Holdings, Inc., effective September 18, 2025 (incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed on September 23, 2025).
10.1
Purchase Agreement, dated September 15, 2025, by and between the Company and Lincoln Park Capital Fund, LLC (incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed on September 16, 2025).
10.2
Registration Rights Agreement, dated September 15, 2025, by and between the Company and Lincoln Park Capital Fund, LLC (incorporated by reference to Exhibit 10.2 of the Registrant’s Current Report on Form 8-K filed on September 16, 2025).
10.3
Amendment No. 1 to BullFrog AI Holdings, Inc.’s 2022 Equity Incentive Plan (incorporated by reference to Exhibit 10.1 of the Registrant’s Current Report on Form 8-K filed on October 24, 2025).
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 September 30, 2025, formatted in Inline XBRL (included in Exhibit
101).
* Filed
herewith.
27
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: November 14, 2025
By:
/ s/ Vininder Singh
Vininder Singh
Chief Executive Officer
Date: November 14, 2025
By:
/s/ Josh Blacher
Josh Blacher
Chief Financial Officer
28
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.