UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
☒
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended March 31, 2024
OR
☐
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from __________to
Commission
File Number 001-41600
BULLFROG
AI HOLDINGS, INC.
(Exact
name of registrant as specified in its charter)
Nevada
84-4786155
(State
or other jurisdiction of
incorporation
or organization)
(I.R.S.
Employer
Identification
No.)
325
Ellington Blvd. , Unit 317
Gaithersburg ,
MD 20878
(Address
of principal executive offices) (Zip Code)
Registrant’s
telephone number, including area code: (240) 658-6710
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☐ No ☒
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes ☒ No ☐.
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer
☐
Accelerated
Filer
☐
Non-accelerated
filer
☒
Smaller
reporting company
☒
Emerging
Growth Company
☒
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act) Yes ☐ No ☒
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class
Trading
symbol
Name
of each exchange on which registered
Common
Stock
$0.00001 par value per share
BFRG
The
Nasdaq Stock Market LLC
(The
Nasdaq Capital Market)
Tradeable
Warrants
BFRGW
The
Nasdaq Stock Market LLC
(The
Nasdaq Capital Market)
The
number of shares of the registrant’s common stock issued and outstanding, as of May 10, 2024 was 7,850,550 .
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
14
Item
3.
Quantitative and Qualitative Disclosures About Market Risk
18
Item
4.
Controls and Procedures
18
PART
II.
OTHER INFORMATION
19
Item
1.
Legal Proceedings
19
Item
1A.
Risk Factors
19
Item
2.
Unregistered Sales of Equity Securities and Use of Proceeds
19
Item
3.
Defaults Upon Senior Securities
19
Item
4.
Mine Safety Disclosures
19
Item
5.
Other Information
19
Item
6.
Exhibits
20
SIGNATURES
21
FORWARD-LOOKING
STATEMENTS
This
report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, or the “Securities
Act,” and Section 21E of the Securities Exchange Act of 1934 or the “Exchange Act.” These forward-looking statements
are subject to certain risks and uncertainties that could cause actual results to differ materially from historical results or anticipated
results.
In
some cases, you can identify forward-looking statements by terms such as “may,” “intend,” “might,”
“will,” “should,” “could,” “would,” “expect,” “believe,” “anticipate,”
“estimate,” “predict,” “potential,” or the negative of these terms. These terms and similar expressions
are intended to identify forward-looking statements. The forward-looking statements in this report are based upon management’s
current expectations and beliefs, which management believes are reasonable. In addition, we cannot assess the impact of each factor on
our business or the extent to which any factor or combination of factors, or factors we are unaware of, may cause actual results to differ
materially from those contained in any forward-looking statements. You are cautioned not to place undue reliance on any forward-looking
statements. These statements represent our estimates and assumptions only as of the date of this report. Except to the extent required
by federal securities laws, we undertake no obligation to update any forward-looking statement to reflect events or circumstances after
the date hereof or to reflect the occurrence of unanticipated events.
You
should be aware that our actual results could differ materially from those contained in the forward-looking statements due to a number
of factors, including:
● our
future financial performance, including our revenue, costs of revenue, operating expenses
and profitability;
● the
sufficiency of our cash and cash equivalents to meet our liquidity needs;
● our
predictions about the proprietary development, digital transformation technology and bio
health businesses and their respective market trends;
● our
ability to attract and retain customers in all our business segments to purchase our products
and services;
● the
availability of financing for smaller publicly traded companies like us;
● our
ability to successfully expand in our three principal business markets and into new markets
and industry verticals; and
● our
ability to effectively manage our growth and future expenses.
Other
risks and uncertainties include such factors, among others, as market acceptance and market demand for our products and services, pricing,
the changing regulatory environment, the effect of our accounting policies, industry trends, adequacy of our financial resources to execute
our business plan, our ability to attract, retain and motivate key personnel, and other risks described from time to time in periodic
and current reports we file with the United States Securities and Exchange Commission, or the “SEC.” You should consider
carefully the statements under this report, which address additional factors that could cause our actual results to differ from those
set forth in the forward-looking statements and could materially and adversely affect our business, operating results and financial condition.
All subsequent written and oral forward-looking statements attributable to us or persons acting on our behalf are expressly qualified
in their entirety by the applicable cautionary statements.
1
PART
1. FINANCIAL INFORMATION
Item
1. Financial Statements
Bullfrog
AI Holdings, Inc.
Condensed
Consolidated Balance Sheets
(Unaudited)
March
31, 2024
December
31, 2023
Assets
Current assets
Cash and cash
equivalents
$ 7,010,717
$ 2,624,730
Prepaid
expenses
632,596
145,882
Total current assets
7,643,313
2,770,612
Property
and equipment, net
5,543
5,974
Total assets
$ 7,648,856
$ 2,776,586
Liabilities and Stockholders’
Equity
Current liabilities
Accounts payable
$ 154,542
$ 103,656
Accrued expenses
182,834
80,694
Short
term insurance financing
507,154
-
Total current liabilities
844,530
184,350
Total liabilities
844,530
184,350
Stockholders’ equity
Series A Convertible Preferred
stock, $ 0.00001 par value, 5,500,000 shares authorized; 73,449 shares issued and outstanding as of March 31, 2024 and December 31,
2023.
1
1
Common stock, $ 0.00001
par value, 100,000,000 shares authorized; 7,850,550 and 6,094,644 shares issued and outstanding as of March 31, 2024 and December
31, 2023, respectively.
79
61
Additional paid-in capital
18,479,738
12,347,098
Accumulated
deficit
( 11,675,492 )
( 9,754,924 )
Total stockholders’
equity
6,804,326
2,592,236
Total liabilities and
stockholders’ equity
$ 7,648,856
$ 2,776,586
See
accompanying notes to unaudited condensed consolidated financial statements.
2
Bullfrog
AI Holdings, Inc.
Condensed
Consolidated Statements of Operations
(Unaudited)
2024
2023
Three Months
Ended
March
31,
2024
2023
Revenue
Revenue
$ -
$ -
Total revenue
-
-
Cost of goods sold
Cost
of goods sold
-
-
Total cost of goods
sold
-
-
Gross profit
-
-
Operating expenses
Research and
development
552,126
369,933
General
and administrative
1,413,592
820,712
Total operating expenses
1,965,718
1,190,645
Loss from operations
( 1,965,718 )
( 1,190,645 )
Other income (expense), net
Interest expense, net
( 3,273 )
( 60,281 )
Loss on conversion of notes
-
( 92,959 )
Interest
income
65,197
18,338
Total other income (expense),
net
61,924
( 134,902 )
Net loss
( 1,903,794 )
( 1,325,547 )
Deemed dividend related
to warrant exercise price adjustment
( 16,774 )
-
Net loss attributatble
to common stockholders
$ ( 1,920,568 )
$ ( 1,325,547 )
Net loss per common
share attributable to common stockholders - basic and diluted
$ ( 0.26 )
$ ( 0.27 )
Weighted average number
of shares outstanding - basic and diluted
7,388,508
4,840,023
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
Capital
Deficit
Equity
Series
A Preferred Stock
Common
Stock
Additional
Paid-in
Accumulated
Total
Stockholders’
Shares
Amount
Shares
Amount
Capital
Deficit
Equity
Balance at December 31, 2022
73,449
$ 1
4,021,935
$ 40
$ 1,341,662
$ ( 4,399,055 )
$ ( 3,057,352 )
Stock-based compensation
-
-
-
-
127,450
-
127,450
Issuance of common stock and warrants, net
of issuance cots
-
-
1,297,318
13
7,293,638
-
7,293,651
Issuance of common stock for services
-
-
7,692
1
49,999
-
50,000
Conversion of convertible debt to common stock
-
-
331,166
3
1,535,612
-
1,535,615
Net loss
-
-
-
-
-
( 1,325,547 )
( 1,325,547 )
Balance at March 31,
2023
73,449
$ 1
5,658,111
$ 57
$ 10,348,361
$ ( 5,724,602 )
$ 4,623,817
Balance at December 31, 2023
73,449
$ 1
6,094,644
$ 61
$ 12,347,098
$ ( 9,754,924 )
$ 2,592,236
Balance
73,449
$ 1
6,094,644
$ 61
$ 12,347,098
$ ( 9,754,924 )
$ 2,592,236
Stock-based compensation
-
-
-
-
335,417
-
335,417
Issuance of common stock and warrants, net
of issuance costs
-
-
1,247,092
13
5,674,638
-
5,674,651
Issuance of common stock pursuant to warrant
exercises
-
-
508,814
5
105,811
-
105,816
Deemed dividend related to warrant price adjustment
-
-
-
-
16,774
( 16,774 )
-
Net loss
-
-
-
-
-
( 1,903,794 )
( 1,903,794 )
Balance at March 31,
2024
73,449
$ 1
7,850,550
$ 79
$ 18,479,738
$ ( 11,675,492 )
$ 6,804,326
Balance
73,449
$ 1
7,850,550
$ 79
$ 18,479,738
$ ( 11,675,492 )
$ 6,804,326
See
accompanying notes to unaudited condensed consolidated financial statements.
4
Bullfrog
AI Holdings, Inc.
Condensed
Consolidated Statements of Cash Flows
(Unaudited)
2024
2023
Three
Months Ended March 31,
2024
2023
Cash flows from operating
activities:
Net loss
$ ( 1,903,794 )
$ ( 1,325,547 )
Adjustments to reconcile net loss to net cash
used in operating activities:
Depreciation
431
431
Stock-based compensation
335,417
127,450
Shares issued for services
-
50,000
Loss on conversion of notes
-
92,959
Changes in operating assets
and liabilities:
Prepaid expense
( 486,714 )
( 791,298 )
Accounts payable
50,886
92,898
Accrued
expenses
102,140
( 608,229 )
Net cash used in operating
activities
( 1,901,634 )
( 2,361,336 )
Cash flows from investing
activities:
Purchases of property
and equipment
-
-
Net cash used in investing
activities
-
-
Cash flows from financing
activities:
Proceeds from issuance of common stock and
warrants, net of issuance costs
5,674,651
7,293,651
Proceeds from warrant exercises
105,816
-
Proceeds from notes payable
-
100,000
Payments of notes payable
-
( 299,950 )
Proceeds from short term insurance financing
561,885
697,534
Payments of short term
insurance financing
( 54,731 )
( 68,048 )
Net
cash provided by financing activities
6,287,621
7,723,187
Net increase in cash and cash equivalents
4,385,987
5,361,851
Cash and cash equivalents,
beginning of period
2,624,730
57,670
Cash
and cash equivalents, end of period
$ 7,010,717
$ 5,419,521
Supplemental cash flow information:
Cash paid for interest
$ 3,273
$ 83,074
Cash paid for taxes
$ -
$ -
Supplemental non-cash activity
Issuance of common stock upon conversion of
notes payable
$ -
$ 1,535,615
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 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. All of our operations are currently conducted through BullFrog AI Holdings, Inc.,
which began operations in February 2020. We are a company focused specifically on advanced AI/ML-driven analysis of complex data sets
in medicine and healthcare. Our objective is to utilize our platform for 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 (AI/ML) has emerged as a digital solution to help address this problem.
We
use artificial intelligence and machine learning to advance medicines for both internal and external projects. Most current AI/ML platforms
still fall short in their ability to synthesize disparate, high-dimensional data for actionable insight. Our analytical platform is composed
of an ensemble of state-of-the-art machine learning and artificial intelligence models. Our core platform technology, named bfLEAP™
is an analytical AI/ML platform developed at The Johns Hopkins University Applied Physics Laboratory (JHU-APL) which 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. We are deploying our analytical platform, including bfLEAP™, for use at several critical stages of
development for internal programs and through strategic partnerships and collaborations with the intention of streamlining data analytics
in therapeutics development, decreasing the overall development costs by decreasing failure rates for new therapeutics, and impacting
the lives of countless patients that may otherwise not receive the therapies they need.
The
proprietary analytical platform utilizes both supervised and unsupervised machine learning. As such, it is able to reveal real and meaningful
connections in the data without the need for a priori hypothesis. Algorithms used in the platform are designed to handle highly imbalanced
data sets and successfully identify combinations of factors that are associated with outcomes of interest. Our platform leverages models
that use both correlative and causative machine learning and artificial intelligence approaches which provide a comprehensive approach
to predictive analysis which is expected to lead to meaningful insights including the molecular drivers of disease.
Our
goal is to improve the odds of success at any stage of pre-clinical and clinical therapeutics development, for in-house programs, and
for our strategic partners and collaborators. Our business model includes enabling the success of ongoing clinical trials and rescuing
late stage failed drugs (i.e., Phase 2 or Phase 3 clinical trial failures) by bringing them in-house for development prior to eventual
divestiture; although, we also consider collaborations for earlier stage drugs. We pursue our drug asset enhancement business by leveraging
the powerful and proven bfLEAP™ AI/ML platform initially developed at JHU-APL. We believe the bfLEAP™ analytics platform
is a potentially disruptive tool for analysis of pre-clinical and/or clinical data sets, such as the robust pre-clinical and clinical
trial data sets being generated in translational R&D and clinical trial settings.
Liquidity
and Going Concern
The
Company has had negative cash flows from operations and operated at a net loss since inception. In the first quarter of 2023, we completed
our initial public offering (“IPO”). In the first quarter of 2024, we received net proceeds of approximately $ 5.7 million
from an underwritten secondary public offering of common stock and warrants. As of March 31, 2024, the Company has a cash balance of
approximately $ 7.0 million. In the absence of significant revenues in 2024, the Company believes that its capital resources are sufficient
to fund planned operations for approximately 12 months from the date of this filing.
6
2.
Summary of Significant Accounting Policies
Basis
of Presentation
The
accompanying condensed consolidated financial statements include the accounts of Bullfrog AI Holdings, Inc. and our 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 our 2023 Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 29, 2024. The unaudited
condensed consolidated financial statements have been prepared on a basis consistent with the audited annual consolidated financial statements
included in the 10-K and, in the opinion of management, include all adjustments of a normal recurring nature necessary to fairly state
our financial position, our results of operations, and cash flows.
The
results for the three months ended March 31, 2024 are not necessarily indicative of the operating results expected for the year ending
December 31, 2024 or any other future period.
In
February 2023, we completed a 1-for-7 reverse split of our common stock . Stockholders’ equity and all references to shares and
per share amounts in the accompanying unaudited condensed consolidated financial statements have been adjusted to reflect the reverse
stock split for all periods presented.
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 to be recognized in the near future will result from discovery and monetization
of new drug targets and intellectual property from data use partnerships focused on analysis of rich proprietary data sets. The target
market for monetization will primarily be large to mid-size biopharmaceutical organizations seeking to build their new drug target pipeline.
A secondary revenue channel is fee for service partnerships with biopharmaceutical companies, and other organizations, of all sizes that
have challenges analyzing data throughout the drug development process. The Company provides the customer with an analysis of large complex
data sets using the Company’s proprietary Artificial Intelligence / Machine Learning 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 receives a cash fee
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.
Significant
Accounting Policies
There
have been no new or material changes to the significant accounting policies discussed in the Company’s audited financial statements
and the notes thereto included in the Annual Report on Form 10-K for the fiscal year ended December 31, 2023.
7
Impact
of Recently Issued Accounting Standards
The
Company has evaluated issued Accounting Standards Updates (“ASUs”) not yet adopted and believes the adoption of these standards
will not have a material impact on its consolidated financial statements.
3.
Convertible Notes
August
2021 Note
In
August 2021, the Company entered into a convertible loan agreement with an unrelated party for a commitment of up to $ 195,000 with a
5 % original issue discount and a 9 % interest rate. The loan was repaid in its entirety in February 2023.
December
2021 Note
In
December 2021, the Company entered into a loan agreement with an unrelated party with a principal amount of $ 25,000 , a 10 % original issue
discount and a 6 % interest rate. Concurrent with the closing of the Company’s IPO, the note converted according to its terms into
6,939 shares of common stock. No gain or loss was recognized on the conversion.
Convertible
Bridge Notes
In
2022, the Company received approximately $ 991,000 of proceeds from the issuance of Convertible Bridge Notes from several offerings. Concurrent
with the closing of the Company’s IPO in February 2023, all of the Convertible Bridge Notes converted according to their terms
into 269,513 shares of common stock. No gain or loss was recognized on the conversions.
4.
Convertible Notes – Related Party
SAFE
Agreement
In
July 2021, the Company entered into a Simple Agreement for Future Equity (SAFE) with a related party at a purchase price of $ 150,000 .
In February 2023, the SAFE terminated and converted into 32,967 shares of common stock according to its terms upon the closing of the
Company’s IPO. The conversion was considered a redemption for accounting purposes and consequently, the Company recognized a $ 63,626
loss on the conversion.
August
2021 Note
In
August 2021, the Company entered into a convertible loan agreement with a related party in the amount of $ 99,900 . In February 2023, the
related party elected to convert the convertible loan into 21,747 shares of common stock according to its terms upon the closing of the
Company’s IPO. The conversion was considered a redemption for accounting purposes and consequently, the Company recognized a $ 29,333
loss on the conversion.
5.
Notes Payable
In
January 2023, the Company entered into a short-term note payable with a principal balance of $ 100,000 , an original discount of 20 % and
a 9 % interest rate. The note was repaid in its entirety in February 2023.
In
February 2023, the Company entered into an agreement to finance a portion of the premium for its Directors and Officers Insurance. The
agreement provided for financing of $ 697,534 of the premium, repayments in 10 equal monthly installments of $ 71,485 each through December
2023 and accrued interest at 6.5 %. The financing was repaid during 2023.
In
February 2024, the Company again entered into an agreement to finance a portion of the premium for its Directors and Officers Insurance.
The agreement provides for financing of $ 561,885 of the premium, repayments in 10 equal monthly installments of $ 58,005 each through
December 2024 and accrued interest at 6.99 %.
6.
Stockholder’s Equity
Preferred
Stock
The
Company has 10,000,000 shares of preferred stock authorized at a par value of $ 0.00001 with 5,500,000 being designated as Series A Convertible
Preferred Stock. Of the 5,500,000 authorized shares of Series A Convertible Preferred Stock, 73,449 were issued and outstanding as of
March 31, 2024. 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.
8
Common
Stock
The
Company has 100,000,000 shares of common stock authorized at a par value of $ 0.00001 .
In
February 2023, the Company completed its IPO for the sale of 1,297,318 units (each, a “Unit,” collectively, the “Units”)
at a price of $ 6.50 per Unit for a total of approximately $ 8.4 million of gross proceeds. Each Unit consisted of one share of the Company’s
common stock, one tradeable warrant (each, a “Tradeable Warrant,” collectively, the “Tradeable Warrants”) to
purchase one share of common stock at an exercise price of $ 7.80 per share , and one non-tradeable warrant (each, a “Non-tradeable
Warrant,” collectively, the “Non-tradeable Warrants”; together with the Tradeable Warrants, each, a “Warrant,”
collectively, the “Warrants”) to purchase one share of the Company’s common stock at an exercise price of $ 8.125 .
In
connection with the completion of its IPO, the Company issued an aggregate of 331,166 shares of common stock upon the conversion of certain
outstanding convertible debt (see Note 4).
In
connection with the IPO, in February 2023, the Company completed a 1-for-7 reverse split of its common stock. Stockholders’ equity
and all references to shares and per share amounts in the accompanying unaudited condensed consolidated financial statements have been
retroactively adjusted to reflect the reverse stock split for all periods presented.
In
February 2023, the Company issued 7,692 shares of common stock for consulting services and recognized $ 50,000 of compensation expense
related to these shares.
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 warrants (collectively the “Units”). The Units were sold at a price of $ 3.782 and the sale
was completed via an underwritten secondary 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. The pre-funded warrants have an exercise price of $ 0.001
and were all exercised in their entirety in the first quarter of 2024.
Dilutive
securities are excluded from the diluted earnings per share calculation because their effect is anti-dilutive. As of March 31, 2024,
5,307,444 warrants and 826,717 options for common shares were excluded from the calculation of net loss per share. As of March 31, 2023,
3,941,113 warrants and 734,492 options for common shares were excluded from the calculation of net loss per 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 authorizes an initial maximum number of shares underlying
awards of 1,035,000 with an automatic annual 15 % increase that began in 2024.
9
Stock
Options
The
following tables summarizes the stock option activity for the three months ended March 31:
Schedule of Stock Options Activity
Number
of Shares
Weighted-Average
Exercise Price
Weighted-Average
Remaining Contractual Term (Years)
Aggregate
Intrinsic Value
Outstanding at December 31, 2023
527,717
$ 4.17
9.00
$ 112,141
Granted
299,000
3.90
Exercised
-
-
Forfeited / canceled
-
-
Outstanding at March 31, 2024
826,717
4.07
9.12
100,452
Vested at March 31, 2024
356,505
4.02
8.63
63,272
Number
of Shares
Weighted-Average
Exercise Price
Weighted-Average
Remaining Contractual Term (Years)
Aggregate
Intrinsic Value
Outstanding at December 31, 2022
69,217
$ 3.06
7.08
$ 117,669
Granted
184,500
2.80
Exercised
-
-
Forfeited / canceled
-
-
Outstanding at March 31, 2023
253,717
2.87
9.21
131,431
Vested at March 31, 2023
108,622
2.98
8.32
44,342
The
fair value of options granted in the three months ended March 31, 2024 and 2023 was estimated using the Black-Scholes option pricing
model based on the assumptions in the table below:
Schedule of Black Scholes Option Pricing Model
Three
Months Ended March 31,
2024
2023
Expected dividend yield
0 %
0 %
Expected volatility
91 %
- 95 %
82 %
- 84 %
Risk-free interest rate
4.0 %
- 4.3 %
3.45 %
Expected life (in years)
5.25
- 6.0
5.5
- 6.0
● Volatility
– The trading volatility was determined by calculating the volatility of the Company’s
peer group.
● Expected
life of options – The expected life of options granted to employees was determined
using the simplified method.
● Risk-free
interest rate – This is the U.S. Treasury rate, having a term comparable to the
expected life of the stock option.
● Dividend
yield – The Company does not expect to pay a dividend in the foreseeable future.
The
weighted-average grant-date fair value of options granted during the three months ended March 31, 2024 and 2023 was $ 2.97 and $ 1.97 ,
respectively.
During
the three months ended March 31, 2024 and 2023, the Company recognized $ 333,020 and $ 105,239 , respectively of compensation expense related
to stock options.
As
of March 31, 2024, the total unrecognized compensation expense related to unvested stock options was approximately $ 1,415,000 , which
the Company expects to recognize over a weighted-average period of approximately 2.0 years.
10
Warrants
The
following table provides details over the Company’s outstanding warrants as of March 31, 2024:
Schedule
of Outstanding Warrants
Exercise
Price
Expiration
Number
of Warrants
$ 0.0007
2030
274,286
$ 2.10 -
$ 2.66
2026
- 2032
446,160
$ 3.36 -
$ 4.27
2028
- 2029
1,933,226
$ 6.51 -
$ 7.80
2026
- 2032
1,484,829
$ 8.125
2027
- 2028
1,443,227
5,581,728
Warrants
Issued in Conjunction with Transactions
During
the year ended December 31, 2023, the Company issued the following warrants as part of the Company’s February 2023 IPO:
● 276,452
contingent warrants to certain debt holders with an exercise price of $ 4.27 and an expiration
date 5 years from issuance. As of March 31, 2024, 204,033 warrants have been exercised and
72,409 remain outstanding. As a result of the February 2024 transaction, the exercise price
of the warrants was reduced to $ 3.782 pursuant to the anti-dilution provision contained in
the warrants. The effect of the change in price was recognized as a deemed dividend of $ 5,794
which increases net loss available to common stockholders for the three months ended March
31, 2024.
● 18,000
contingent warrants as fees to the Company’s underwriters with an exercise price of
$ 8.125 and an expiration date 4 years from issuance. As of March 31, 2024, none of these
warrants have been exercised. As a result of the February 2024 transaction, the exercise
price of the warrants was reduced to $ 3.782 pursuant to the anti-dilution provision contained
in the warrants. The effect of the change in price was recognized as a deemed dividend of
$ 10,980 which increases net loss available to common stockholders for the three months ended
March 31, 2024.
● 1,297,318
tradable warrants with an exercise price of $ 7.80 and an expiration date 5 years from issuance.
Through March 31, 2024, 100 warrants have been exercised.
● 1,297,318
non-tradable warrants with an exercise price of $ 8.125 and an expiration date 5 years from
issuance. As of March 31, 2024, none of these warrants have been exercised.
● 153,409
tradeable warrants to our underwriters pursuant to the overallotment options with an exercise
price of $ 7.80 and an expiration date 5 years from issuance. As of March 31, 2024, none of
these warrants have been exercised.
● 153,409
non-tradeable warrants to our underwriters pursuant to the overallotment options with an
exercise price of $ 8.125 and an expiration date 5 years from issuance. As of March 31, 2024,
none of these warrants have been exercised.
During
the three months ended March 31, 2024, the Company issued the following warrants as part of the
Company’s secondary public offering:
● 1,507,139
warrants to purchase shares of the Company’s common stock at 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 and an expiration date 5 years
from issuance pursuant to the underwriters’ overallotment option. As of March 31, 2024,
16,000 of these warrants have been exercised and 1,709,521 remain outstanding.
● 478,429
pre-funded warrants with an exercise price of $ 0.001 . As of March 31, 2024, all of these
pre-funded warrants have been exercised.
● 90,428
warrants with an exercise price of $ 4.16 per share and an expiration date 5 years from issuance
to our underwriters. The warrants are valued at approximately $ 263,000 and as of March 31,
2024, none of these warrants have been exercised.
11
Warrants
Issued as Consideration for Services
The
following table summarizes the activity for warrants issued as consideration for services for the three months ended March 31, 2024 and
the year ended December 31, 2023:
Schedule
of Warrant Activity
Number
of Warrants
Weighted-Average
Exercise Price
Weighted-Average
Remaining Contractual Term (Years)
Aggregate
Intrinsic Value
Outstanding at December 31, 2022
678,176
$ 1.57
7.6
$ 2,131,123
Granted
-
-
Exercised
-
-
Forfeited / canceled
-
-
Outstanding at December 31, 2023
678,176
1.57
6.6
1,209,136
Granted
-
-
Exercised
( 14,285 )
2.66
Forfeited / canceled
-
-
Outstanding at March 31, 2024
663,891
1.55
6.3
1,170,302
Vested at March 31, 2024
660,910
1.54
6.3
1,168,664
During
the three months ended March 31, 2024 and 2023, the Company recognized $ 2,397 and $ 22,211 , respectively, of compensation expense related
to certain warrants.
As
of March 31, 2024, the total unrecognized compensation expense related to unvested warrants was $ 610 to be recognized over approximately
0.4 years.
7.
Income Taxes
The
Company has not recorded any tax provision or benefit for the three months ended March 31, 2024 and 2023. 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 loss carryforwards, and research and development credits are not more-likely-than-not to be realized at March
31, 2024 and December 31, 2023.
8.
Material Agreements
JHU-APL
Technology License
In
February 2018, the Company entered into an exclusive, world-wide, royalty-bearing license from JHU-APL. 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 License Agreement, JHU 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 IPO. Under the terms of the License Agreement, JHU will be entitled to an eight percent ( 8 %) royalty on net sales for the services
provided by the Company as well as fifty percent ( 50 %) of all sublicense revenues received by the Company on services and sublicenses
in which the JHU licensed technology was utilized. In addition, the Company is required to pay JHU an annual maintenance fee of $ 1,500 .
Minimum annual royalty payments are $ 20,000 for 2022, $ 80,000 for 2023, and $ 300,000 per year for 2024 and beyond. If cumulative annual
royalty payments do not reach these levels, the amount due to JHU to reach the annual minimum is due by January 31st of the following
year. Failure to make annual royalty payments is considered a material breach under the agreement and upon notice from JHU of a material
breach, the Company shall have 60 days to cure the material breach. 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 new license provides
additional intellectual property rights including patents, copyrights, and knowhow to be utilized under the Company’s bfLEAP™
analytical AI/ML platform. This license supersedes the previous license. In consideration of the new license, the Company issued 39,879
shares of common stock to JHU. Under the terms of the new License Agreement, JHU 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 license was utilized. The new license also contains tiered sub licensing fees that start at 50 % and reduce to 25 % based on revenues.
In addition, under the new license agreement, the minimum annual royalty payments are $ 30,000 for 2022, $ 60,000 for 2023, and $ 300,000
per year for 2024 and beyond.
12
In
May 2023, the Company and JHU-APL entered into Amendment number 1 of the July 2022 License Agreement whereby the Company gained access
to certain improvements including additional patents and knowhow in exchange for a series of payments totaling $ 275,000 . The first of
these payments for $ 75,000 was paid in July 2022 and the remaining payments of $ 75,000 , $ 75,000 , and $ 50,000 are due in years 2024, 2025,
and 2026, respectively. The amendment also reduced the 2023 minimum annual royalty payment to $ 60,000 , all other financial terms remain
the same. As of March 31, 2024, we have accrued $ 75,000 of the 2024 minimum annual royalty payments.
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 (HCC). The license
covers methods claimed in three US 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.
Under the terms of the License Agreement, GWU will be entitled to a three percent ( 3 %) royalty on net sales subject to quarterly minimums
once the first sale has occurred subsequent to regulatory approval, as well sublicense or assignment fees in the event the Company sublicenses
or assigns their rights to use the technology. The Company will also reimburse GWU for previously incurred and ongoing patent costs.
The Sublicense and Assignment fee amounts decline as the Company advances the clinical development of the licensed technology. The license
agreement also contains milestone payments for clinical development through the approval of an NDA and commercialization. As of March
31, 2024, there has been no accrual for royalties since we have not begun to generate applicable revenue. The Company assessed whether
the license should be capitalized and determined that the licensed program is in the early stage and therefore may not be recoverable;
the Company expensed the license fee and will expense development costs until commercial viability is likely.
Johns
Hopkins University – Mebendazole License
In
February 2022, the Company entered into an exclusive, world-wide, royalty-bearing license from Johns Hopkins University (JHU) for the
use of an improved formulation of Mebendazole for the treatment of any human cancer or neoplastic disease. This formulation shows potent
activity in animal models of 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 will receive a staggered Upfront License Fee of $ 250,000 . The initial payment for $ 50,000 was paid and the remaining
balance of $ 200,000 was paid after the Company completed its IPO. 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 2023, $ 10,000 for 2024, $ 20,000 for 2025, $ 30,000 for 2026, and $ 50,000 for 2027 and each year after until the first commercial
sale, after which, the annual minimum royalty shall be $ 250,000 . The license agreement also contains milestone payments for clinical
development steps through the approval of an NDA and commercialization. As of March 31, 2024 and December 31, 2023, the balance of accrued
expense related to this license agreement was $ 5,000 and $ 10,000 , respectively. 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
US and worldwide patent applications. In consideration for the rights granted to the Company under the License Agreement, JHU and IOCB
will receive a staggered upfront license fee of $ 100,000 . The Company will also reimburse JHU and IOCB for previously incurred patent
costs. Under the terms of the License Agreement, JHU and IOCB will be entitled to 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 2027, $ 10,000 for 2028, $ 20,000 for 2029, $ 30,000 for 2030, and $ 50,000 for 2031 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. No expenses have been accrued as of any of the periods
presented. 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.
13
Item
2. Management’s Discussion and Analysis of Financial Conditions and Results of Operations
References
in this Management’s Discussion and Analysis of Financial Condition and Results of Operations to “us”, “we”,
“our” and similar terms refer to the Company. The following discussion and analysis of our financial condition and results
of operations should be read in conjunction with (1) our 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, 2023, filed with the
Securities and Exchange Commission on March 29, 2024. 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 founding
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, BullFrog AI Holdings secured the original exclusive, worldwide, royalty-bearing license from JHU-APL. 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 license agreement in July 2022 that provides the Company with
new intellectual property and also encompasses most of the intellectual property from the February 2018 license. Our objective is to
utilize our AI/ML platform with a precision medicine approach toward drug development with biopharmaceutical collaborators, as well as
for 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 that 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 clinical trials or rescue late-stage
failed drugs (i.e., Phase 2 or Phase 3 clinical trial failures) for in-house development and divestiture; although, we also consider
collaborations for earlier stage drugs.
In
July 2022, the Company entered into an exclusive, worldwide, royalty-bearing license from JHU-APL for the additional technology. The
new license provides additional intellectual property rights including patents, copyrights, and knowhow to be utilized under the Company’s
bfLEAP™ analytical AI/ML platform. In consideration of the new license, the Company issued to JHU-APL 39,879 shares of common stock.
In September 2020 and October 2021, the Company executed amendments to the original license which represents improvements and new advanced
analytics capabilities. In consideration of the rights granted to the Company under the original License Agreement, the Company granted
JHU 178,571 warrants exercisable to purchase shares of common stock at $2.10 per share. Under the terms of the new License Agreement,
JHU 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 license was utilized. The new license also contains tiered sub licensing fees
that start at fifty (50%) percent and reduce to twenty-five (25%) percent based on revenues. The Company and JHU-APL entered into Amendment
number 1 of the July 2022 License Agreement whereby the Company gained access to certain improvements including additional patents and
knowhow in exchange for a series of payments totaling $275,000. The first of these payments for $75,000 was paid in July 2022 and the
remaining payments of $75,000, $75,000 and $50,000 are due in years 2024, 2025, and 2026, respectively. The amendment also reduced the
2023 minimum annual royalty payment to $60,000, all other financial terms remain the same. As a result of this Amendment, the minimum
annual payments were $30,000 for 2022 and $60,000 for 2023, and the minimum annual payments will be $300,000 for 2024 and beyond, all
of which are creditable by royalties.
14
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
have staffed our business using funds from our initial public offering and have entered into partnerships and relationships and recently
completed our first commercial service contract with a leading rare disease non-profit organization for AI/ML analysis of late-stage
clinical data. We have also acquired the rights to a series of preclinical and early clinical drug assets from universities, as well
as 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 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 have 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 partnership 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 multiple revenue generating strategic partnership deals with biopharmaceutical
companies. We intend on securing the rights to other proprietary data sets and repeating 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/or
drug product for our R&D and clinical trials, and, in some cases, may also require 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 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 IPO in February 2023, aided by the receipt of the IPO proceeds, we have initiated several initiatives: Investor relations
and marketing to promote and raise awareness of the company in the financial and business sectors, research and development, collaboration
with the J Craig Venter Institute and, in the quarter ended September 30, 2023, we completed a preclinical study for our Mebendazole
prodrug program. The Company is actively engaged in developing and pursuing new intellectual property as it strives to continuously evolve
its AI/ML platform. Additionally, the Company has engaged a business development firm specializing in the biopharmaceutical industry
to seek and secure a strategic development partner for our Mebendazole program.
Internally,
the Company has added incremental staff to accelerate execution, and the development of processes and custom scripts for use in performing
new drug target discovery and analytical services for customers, while also launching initiatives targeting large public health data
sources and seeking access to proprietary health data sources, such as our agreement with the Lieber Institute for Brain Development.
We also transitioned 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 that did not convert
into common stock as well as other debts accrued over time to our staff, employees and consultants as well as obligations related to
the acquisition of our licensed drug programs.
15
In
the first quarter of 2024, we received net proceeds of approximately $5.7 million from an underwritten secondary public offering of common
stock and warrants. As of March 31, 2024, the Company has a cash balance of approximately $7.0 million. In the absence of significant
revenues in 2024, the Company believes that its capital resources are sufficient to fund planned operations for approximately 12 months
from the date of this filing.
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 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/or 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, using our proprietary
AI/ML technology to advance the development and make discoveries, 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
While
we generated our first revenues in late 2022 from our services provided to a pharmaceutical customer, in the third quarter of 2023 we
completed our first commercial service contract and recognized revenue in the amount of $65,000. We did not generate any revenue during
the three months ended March 31, 2024.
Research
and Development Costs and Expenses
Research
and development expenses consist primarily of costs related to the acquisition of licensed technology, fees paid to external service
providers and internal costs for personnel working on research and development activities, including work on our proprietary platform
which utilizes bfLEAP™ and an ensemble of AI/ML tools and models.
Research
and development costs are expensed as incurred. Estimates are used in determining the expense liability of certain costs where services
have been performed but not yet invoiced.
We
anticipate our research and development costs continuing to increase 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 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 pursue. Further, we anticipate our research and development costs will increase as we add additional staff and perform
analytical work aimed at target discovery on proprietary data sets through our partnering efforts as well as with prospective customers.
General
and Administrative Expenses
General
and administrative expenses consist primarily of personnel related costs, including non-cash stock-based compensation, as well as accounting
and consulting services, insurance expense, and legal fees relating to corporate matters. We anticipate that our general and administrative
expenses will increase in the future to support our target discovery efforts, service offerings, and clinical and pre-clinical research
and development activities associated with strategic partnering and collaborations.
16
Results
of Operations - Comparison of Three Months Ended March 31, 2024 and 2023
March
31,
Net
Change
2024
2023
Operating expenses:
Research and
development
$ 552,126
$ 369,933
$ 182,193
General and administrative
1,413,592
820,712
592,880
Total operating expenses
$ 1,965,718
$ 1,190,645
$ 775,073
Research
and Development
Our
research and development expenses for the three months ended March 31, 2024 increased, compared to the same period ended March 31, 2023,
primarily due to increased personnel costs due to the hiring of several additional technical staff as well as our Chief Science Officer.
In addition, in the first quarter of 2024, we engaged disease experts as area consultants, we expanded our target discovery efforts,
and we also initiated a preclinical obesity study related to siRNA program.
General
and Administrative
Our
general and administrative expenses for the three months ended March 31, 2024 increased, compared to the same period ended March 31,
2023, primarily due to increased personnel costs due to the hiring of several additional staff, as well as associated increases in equity
compensation costs and recruiting fees as we work to expand our technical staff and capabilities.
Other
Income (Expense), Net
Interest
expense decreased $57,008 for the three months ended March 31, 2024, compared to the same period ended March 31, 2023, due to the majority
of our debt converting or being paid off in the first quarter of 2023. Interest income increased by $46,859 for the three months ended
March 31, 2024, compared to the same period ended March 31, 2023, due to interest earned on cash held in an overnight sweep account.
Results
of Operations
Liquidity
and Capital Resources
In
2022, the Company received net proceeds from the sale of Convertible Bridge Notes of approximately $1,016,000 and repaid the unsecured
promissory notes sold in 2021 in the amount of $49,000. The Company sold one additional promissory note and received net proceeds of
$100,000 in January 2023.
Through
March 31, 2024, the Company has an accumulated deficit of approximately $11,675,000 and has funded its operations through the sale of
common stock and debt. We anticipate that our expenses will increase in the future to support our target discovery activities, service
offerings, clinical and pre-clinical research and development activities associated with strategic partnering and collaborations, as
well as acquired product candidates and the increased costs of operating as a public company.
The
Company’s current operations include BullFrog AI, Inc. and BullFrog Management, LLC, which are wholly owned subsidiaries of BullFrog
AI Holdings, Inc., which is a holding company that depends upon the sale of its securities and cash generated through its subsidiaries
to fund consolidated operations.
On
February 16, 2023, the Company completed its IPO of 1,297,318 units (each, a “Unit,” collectively, the “Units”)
at a price of $6.50 per unit for a total of approximately $8.4 million of gross proceeds to the Company. Each Unit consists of one share
of the Company’s common stock, one tradeable warrant (each, a “Tradeable Warrant,” collectively, the “Tradeable
Warrants”) to purchase one share of common stock at an exercise price of $7.80 per share, and one non-tradeable warrant (each,
a “Non-tradeable Warrant,” collectively, the “Non-tradeable Warrants”; together with the Tradeable Warrants,
each, a “Warrant,” collectively, the “Warrants”) to purchase one share of the Company’s common stock at
an exercise price of $8.125. In connection with the IPO, the Company also completed a 1-for-7 reverse stock split of our common stock.
17
In
connection with the IPO, a SAFE and convertible loan agreement held by a related party converted into 55,787 shares of post reverse split
common stock. Additionally, all outstanding convertible bridge notes and accrued interest through November 30, 2022 were converted into
276,289 shares of common stock and 276,289 warrants to purchase common stock were issued to the Convertible Bridge Note holders at conversion.
The convertible bridge note conversions and the warrant exercise pricing were determined using a $25 million company valuation immediately
before the IPO.
Between
April 5 and April 13, 2023, the holders of warrants exercised 436,533 warrants for common stock at various exercise prices and the Company
received proceeds of approximately $1,495,000.
In
the first quarter of 2024, we complete an underwritten secondary offering of common stock and warrants generating approximately $5.7
million of net proceeds.
In
the first quarter of 2024, holders exercised warrants (including prefunded warrants from the secondary offering) to purchase 508,814
shares of common stock generating proceeds of approximately $106,000.
In
the absence of significant revenues in 2024, management believes the Company’s capital resources are sufficient to fund planned
operations for approximately 12 months from the date of this filing.
Consolidated
Cash Flow Data
Three
Months Ended March 31,
2024
2023
Change
Net cash (used in) provided by
Operating activities
$ (1,901,634 )
$ (2,361,336 )
$ 459,702
Investing activities
-
-
-
Financing
activities
6,287,621
7,723,187
(1,435,566 )
Net increase in cash
and cash equivalents
$ 4,385,987
$ 5,361,851
$ (975,864 )
Cash
Flows Used in Operating Activities
Net
cash used in operating activities for the three months ended March 31, 2024 decreased compared to the same period ended March 31, 2023
primarily due to paying down accrued expenses for technology access, consultants, and compensation in 2023, partially offset by increased
operating costs in 2024.
Cash
Flows Used in Investing Activities
There
was no cash used in investing activities during the three months ended March 31, 2024 or 2023.
Cash
Flows Provided by Financing Activities
Net
cash provided by financing activities for the three months ended March 31, 2024 decreased compared to the same period ended March 31,
2024 primarily due to proceeds from our Initial Public Offering in February 2023 as compared to proceeds from our secondary offering
in February 2024.
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 transitioning to and will maintain disclosure controls and procedures that are designed to ensure that information required to be
disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized and timely reported as provided
in SEC rules and forms and that such information is accumulated and communicated to our management, as appropriate, to allow for timely
decisions regarding required disclosure. We will periodically review the design and effectiveness of our disclosure controls and procedures,
including compliance with various laws and regulations that apply to our operations. We will make modifications to improve the design
and effectiveness of our disclosure controls and procedures and may take other corrective action if our reviews identify a need for such
modifications or actions. In designing and evaluating the disclosure controls and procedures, we recognize that any controls and procedures,
no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and we will
apply judgment in evaluating the cost-benefit relationship of possible controls and procedures. In addition, the design of any system
of controls 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; over time, controls may become inadequate
because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations
in a control system, misstatements due to error or fraud may occur and not be detected.
18
Changes
in Internal Control Over Financial Reporting
During
the 3 months ended March 31, 2024, the Company transitioned its day-to-day accounting processes to a new external firm including automating
its vendor payments while also initiating the transfer of the overall process to an enterprise type accounting platform. These changes
in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during
the quarter ended March 31, 2024 are intended to enhance our internal control over financial reporting.
PART
II. OTHER INFORMATION
Item
1 Legal Proceedings.
To
our best knowledge, we are currently not a party to any legal proceedings that, individually or in the aggregate, are deemed to be material
to our financial condition or results of operations.
Item
1A Risk Factors.
Smaller
reporting companies are not required to provide the information required by this item.
Item
2 Unregistered Sales of Equity Securities and Use of Proceeds.
There
were no issuances of unregistered sales of equity securities during the three months ended March 31, 2024.
Use of Proceeds.
We
continue to use the proceeds from our IPO and secondary offering for our operations.
Item
3 Defaults Upon Senior Securities.
None.
Item
4 Mine Safety Disclosures.
Not
applicable.
Item
5 Other Information.
(c)
Insider Trading Arrangements
Trading
Plans
On
June 6, 2023 , Vininder Singh, the Chief Executive Officer and Director of the Company, entered into a 10b5-1 sales plan (the “10b-5
Sales Plan”) intended to satisfy the affirmative defense of Rule 10b5-1(c) under the Exchange Act. The 10b5 Sales Plan provides
for the sale of up to 1,000,000 shares of common stock and will remain in effect until the earlier of (1) September 30, 2024; 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, 100,000 shares were sold under the plan in the first quarter of 2024 and 50,000 shares were sold under the plan in September 2023.
No
other directors or executive officers of the Company adopted , modified or terminated any contract, instruction or written plan for the
purchase or sale of the Company’s securities that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c)
or any non-Rule 10b5 trading arrangement, (as defined in Item 408(c) of Regulation S-K) during the quarterly period covered by this report.
19
Item
6. EXHIBITS
Exhibit
No.
Description
31.1
*
Certification of Chief Executive Officer pursuant to Rule 13a-14(a)/15d-14(a).
31.2
*
Certification of Chief Financial Officer pursuant to Rule 13a-14(a)/15d-14(a).
32.1
*
Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2
*
Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.INS
*
Inline
XBRL Instance Document.
101.SCH
*
Inline
XBRL Taxonomy Extension Schema Document.
101.CAL
*
Inline
XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF
*
Inline
XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB
*
Inline
XBRL Taxonomy Extension Label Linkbase Document.
101.PRE
*
Inline
XBRL Taxonomy Extension Presentation Linkbase Document.
104
The
cover page from the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, formatted in Inline XBRL
(included in Exhibit 101).
* Filed
herewith.
20
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed
on its behalf by the undersigned thereunto duly authorized.
Bullfrog AI Holdings, Inc.
Date:
May 10, 2024
By:
/s/
Vininder Singh
Vininder Singh
Chief Executive Officer
Date:
May 10, 2024
By:
/s/
Dane Saglio
Dane Saglio
Chief Financial Officer
21
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.