What changed in this filing

/stocks — the workspaceLOADING

Item 7. Management’s Discussion and Analysis

2024-03-29 compared with 2023-04-25 · 218 added, 168 removed, 82 unchanged (82% of the section changed)

25 unchanged sentences

bfLEAP™) was created from technology originally developed at The Johns Hopkins University Applied Physics Laboratory

February 2018, BullFrog AI Holdings secured the original exclusive, worldwide, royalty-bearing license from JHU-APL for the

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 for a precision medicine approach

toward drug development with biopharmaceutical collaborators, as well as our own internal clinical development programs.

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.

February 2018, BullFrog AI Holdings secured the original exclusive, worldwide, royalty-bearing license from JHU-APL for the technology.

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.

objective is to utilize our for 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 that lead to faster, less expensive drug approvals.

aim is to improve the odds of success in each stage of developing medicine, ranging from early pre-clinical through late-stage clinical

6 unchanged sentences

July 8, 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 of 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 3% for internally

development 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, the Company is required to pay JHU an annual maintenance fee of $1,500.

annual payments are set to be $30,000 for 2022, $80,000 for 2023, and $300,000 for 2024 and beyond, all of which are creditable by royalties.

will 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.

have begun to ramp our business using funds from our initial public offer offering and through our partnerships and relationships.

We currently have a strategic relationship with a leading rare disease non-profit organization for AI/ML analysis of late-stage

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 of 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

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 3% for internally developed drug projects in which the JHU license was utilized.

new license also contains tiered sub licensing fees that start at 50% and reduce to 25% based on revenues.

On May 31, 2023, the

Company and JHU-APL entered into Amendment number 1 of the July 8, 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.

these payments for $75,000 was due in July 2023 followed by annual payments of $75,000, $75,000 and $50,000 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

As a result of this Amendment, the minimum annual payments are set to be $30,000 for 2022, $60,000 for 2023, and $300,000

for 2024 and beyond, all of which are creditable by royalties.

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.

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 hepatoceullar carcinoma (liver cancer), and other

liver diseases.

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 a 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 (GMP) industry-standard guidelines, 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.

Over the next 24 months, the Company

expects to spend approximately $2.1 million on service offering products, preclinical IND enabling activities and on R&D to

enable future clinical trials evaluating our drug assets for new disease indications.

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.

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.

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 (GMP) industry-standard guidelines, 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.

completing our IPO on February 14, 2023, aided by the receipt of the IPO proceeds, we have initiated several initiatives:

relations and marketing to promote and raise awareness of the company in the financial and business sectors, research and

development, collaboration with J Craig Venter Institute and in the quarter ended September 30, 2023, completed a preclinical study

for our Mebendazole prodrug program.

The Company is actively engaged in developing and seeking out 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.

the Company has added incremental staff to accelerate execution, and the development of processes and custom scripts for use in performing

analytical services for customers, while also launching initiatives targeting large public health data sources and seeking access to

proprietary health data sources.

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.

February 2024 the Company received net proceeds of approximately $4.9 million dollars from an underwritten public offering of 1,507,139

shares of common stock (or pre-funded warrants in lieu thereof) and accompanying warrants to purchase 1,507,139 shares of common stock

at an offering price of $3.782.

The 5 year warrants have an exercise price of $4.16.

On February 21, 2024, the underwriters elected to

exercise the over-allotment option for the purchase of an additional 218,382 shares of common stock, and the Company received additional

net proceeds of approximately $750,000, pursuant to the exercise of the over-allotment.

In the absence of significant revenues in 2024

the Company believes that its capital resources are sufficient to fund planned operations for more than 12 months from the date of this

Company has a unique strategy designed to reduce risk and increase the frequency of cash flow.

5 unchanged sentences

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 work flow or analysis of discrete data sets.

into the client’s workflow or analysis of discrete data sets.

the future, the second part of our strategy involves acquiring the rights to clinical stage drugs, using our bfLEAP technology to design

6 unchanged sentences

the years ended December 31, 2023 and 2022

late 2022, the Company recognized its first service revenues of $10,000 related to an analysis contract with a small pharmaceutical

The Company previously had not recorded any revenues.

Through the end of 2022, the Company has an accumulated deficit of

approximately $4,399,000.

Net loss from operations in 2022 was approximately $2,455,000 versus $555,000 in 2021.

The 2022 increase

reflects the full year costs of engaging advisors and consultants and other costs associated with preparing the Company for its

initial public offering including the costs related to auditing the Company’s past and current financial statements.

in operations in 2022 was approximately $911,000 versus approximately $382,000 in 2021 and net cash inflows from financing

activities in 2022 was approximately $967,000 versus approximately $387,000 in 2021.

and Costs of Goods Sold

recognized $65,000 and $10,000 in revenue and $5,200 and $800 in costs of goods sold during the years ended December 31, 2023 and 2022,

respectively.

Year ended December 31,

Operating expenses:

Research and development

General and administrative

Total operating expenses

and Development

research and development expenses for the year ended December 31, 2023 increased by $823,344 compared to the same period ended December

31, 2022, primarily due to the inclusion of the cost of salaries and consulting fees in 2023 as we initiated our collaboration with J

Craig Venter Institute and completion of a preclinical study for our Mebendazole prodrug program, as well as the cost of acquiring access

to additional technology from JHU-APL related to bfLEAP™ pursuant to Amendment 1 of the July 2022 License Agreement.

majority of the research and development expenses were directly related to the acquisition of two drug development product candidates

including Mebendazole.

and Administrative

general and administrative expenses for the year ended December 31, 2023 increased by $2,138,979, compared to the same period ended December

31, 2022, primarily due to higher salary and consulting costs reflecting an increased level of service as well the initiation of investor

relations and marketing efforts and the transition of our accounting and financial reporting process to support a public company.

2023 period also reflects approximately $120,000 in recruiting fees related to staff additions.

Income (Expense), Net

expense decreased $268,056 for the year ended December 31, 2023, compared to the same period ended December 31, 2022 due to the majority

of our debt converting or being paid off in the first quarter of 2023.

The loss on the conversion of notes of $92,959 for the year ended

December 31, 2023 was due to the conversion of the convertible notes.

Other income increased by $183,244 due to interest earned on our

IPO proceeds which we hold in an overnight sweep account.

and Capital Resources

2021, we received net proceeds of approximately $387,000, primarily from the sale of a SAFE note ($150,000) and a convertible promissory

note ($99,900) and three unsecured promissory notes ($49,000) to a related party.

In addition, in July and December 2021, the Company

sold convertible bridge notes to two unrelated parties and received net proceeds of approximately $88,000.

In the period ended December

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.

2021, the Company primarily operated with only one full time employee and a series of consultants.

During this period, the primary activities

technology evaluation, acquisition and validation, capital acquisition and business development activities which in general,

have readied the Company for contract services while exploring strategic partnering and asset acquisition.

The majority of this was paid

to employees and consultants as compensation.

In 2021, the Company used approximately $382,000 on operating activities including approximately

$203,000 in salaries and approximately $150,000 on professional services and fees directly related to preparation for the intended IPO.

The Company also made payments totaling $25,000 under two evaluation/option agreements for the two drug development programs licensed

In 2022, three consultants engaged by the Company became part time employees and the Company now has four employees.

year ended December 31, 2022, the Company used approximately $911,000 on operating activities versus approximately $382,000 for the same

period in 2021.

The 2022 cash use included approximately $548,000 in salaries, approximately $634,000 in consulting and professional

fees including legal, accounting and auditing fees as well as consulting fees for operational activities and approximately $609,000 in

technology license fees, patent cost reimbursements and minimum annual royalties which has been recorded as a research & development

The Company sold one additional promissory note and received net proceeds of

$100,000 in January 2023.

the year ended December 31, 2022, the Company used approximately $911,000 on operating activities versus approximately $382,000 for

the same period in 2021.

The 2022 cash use included approximately $548,000 in salaries, approximately $634,000 in consulting and

professional fees including legal, accounting and auditing fees, as well as consulting fees for operational activities and

approximately $609,000 in technology license fees, patent cost reimbursements and minimum annual royalties which has been recorded

as a research & development expense.

December 31, 2023, the Company has an accumulated deficit of approximately $9,755,000 and funded its operations through the sale of common

1 unchanged sentence

We anticipate that our expenses will increase in the future to support our service offerings, clinical and pre-clinical

research and development activities associated with strategic partnering and collaborations as we well as acquired product candidates

and the increased costs of operating as a public company.

These increases will likely include increased costs related to the hiring of

additional personnel and fees to outside consultants, lawyers and accountants, among other expenses.

Additionally, we anticipate increased

costs associated with being a public company including expenses related to services associated with maintaining compliance with exchange

listing and Securities and Exchange Commission requirements, insurance, and investor relations costs.

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.

These increases could include increased costs related to the hiring of additional

personnel and fees to outside consultants, lawyers and accountants, among other expenses.

Additionally, we anticipate increased costs

associated with being a public company including expenses related to services associated with maintaining compliance with exchange listing

and Securities and Exchange Commission requirements, insurance, and investor relations costs.

Company’s current operations include BullFrog AI, Inc.

2 unchanged sentences

to fund consolidated operations.

December 31, 2022, the Company received net proceeds of approximately $1,016,000 from the sale of convertible promissory notes and warrants.

On February 16, 2023, the Company completed

its initial public offering 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.

The offering closed on February 16, 2023.

connection with and prior to the consummation of the initial public offering, the Company effected a reverse split of its

outstanding shares of common stock at a ratio of 1:7 - 1 share of new common stock for 7 shares of then outstanding common stock.

Also in connection with the initial public offering, 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 common stock and 276,289 warrants to purchase common stock (post

reverse stock split) were issued to the Convertible Bridge Note holders at conversion.

The convertible bridge note conversions and

the warrant exercise pricing was determined using a $25 million dollar company valuation immediately before the initial public

April 5 and April 13, 2023, the holders of warrants exercised 436,533 (post reverse stock split) warrants for common stock at

various exercise prices and the Company received proceeds of approximately $1,495,000.

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.

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.

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 dollar company valuation

immediately before the IPO.

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.

the absence of revenues in 2024 management believes the company’s capital resources are sufficient to fund planned operations for

substantially longer than 12 months from the date of this filing.

Cash Flow Data

Year ended December 31,

Net cash (used in) provided by

Research and development Operating activities

$ (6,001,299 )

$ (5,090,409 )

General and administrative Investing activities

Financing activities

Net increase in cash and cash equivalents

Flows Used in Operating Activities

cash used in operating activities for the year ended December 31, 2023 increased by $5,090,409 compared to the same period ended December

31, 2022 primarily due to paying down accrued expenses for technology access, consultants, and compensation in 2023, coupled with increased

operating costs, including D&O insurance premiums.

Flows Used in Investing Activities

was no cash used in investing activities during the year ended December 31, 2023.

Flows Provided by Financing Activities

cash provided by financing activities for the year ended December 31, 2023 increased by $7,601,069, compared to the same period ended

December 31, 2022 primarily due to the completion of our Initial Public Offering in February 2023 and proceeds received pursuant to warrant

Accounting Policies

6 unchanged sentences

Operations Overview

generated our first revenues in late 2022 from our services provided to a pharmaceutical customer.

We have service contracts with two

organizations and currently have multiple discussions underway and anticipate, although there can be no assurance, entering into additional

service agreements and business relationships in 2023.

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 have service contracts with two organizations

and currently have multiple discussions underway, although there can be no assurance of entering into additional service agreements and

business relationships in 2024.

classify our operating expenses into two categories:

5 unchanged sentences

These activities and related expenditures have been recorded and reported as General and Administrative in our Financial Statements.

In 2022, we licensed two drug development programs from universities and also entered into a new license with JHU-APL for new IP and other

enhancements used with our bfLEAP™ platform.

In 2022, we expended appropriately $608,000 on license related payments for our bfLEAP™

AI/ML platform and our two drug development programs from universities.

We expect that our research and development expenses will increase

in 2023 as we initiate activities directed towards the development of service offering products, collaborations (JCVI) and preclinical

IND enabling studies.

In 2022, we licensed two drug development programs from universities and also entered into a new license with JHU-APL for new IP and

other enhancements used with our bfLEAP™ platform.

In 2022, we expended appropriately $608,000 on license related payments for

our bfLEAP™ AI/ML platform and our two drug development programs from universities.

We expect that our research and development

expenses will increase in 2024 as we initiate activities directed towards the development of service offering products, collaborations

(JCVI) and preclinical studies aimed at generating the data to enable the filing of an Investigational New Drug (IND) application.

and Development Costs and Expenses

and development costs and expenses consist primarily of costs related to the acquisition of licensed technology and fees paid to external

service providers.

We anticipate our research and development costs could become significant as we execute on our business plan and begin

conducting preclinical research and development activities directed at securing development partners and filing Investigational New Drug

(IND) applications for our licensed drug development programs describes 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.

and development costs and expenses in 2022 consisted primarily of costs related to the acquisition of licensed technology.

have initiated development activities on our licensed drug candidates and our discovery collaboration with JCVI.

In addition to fees

paid to external service providers, we are also allocating internal costs for personnel working on these efforts in addition to personnel

costs related to our internal efforts to develop our product and service offerings using bfLEAP™.

We anticipate our research and

development costs could become significant as we execute on our business plan and begin conducting preclinical research and development

activities directed at securing development partners and filing an IND 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.

and Administrative Expenses

anticipation of the initial public offering, a management team with deep industry experience was been identified and engaged as

employees and consultants to assist the Company in preparing for the initial public offering and subsequently, to operate and

function as a public company.

Through 2021, the Company primarily operated with only one full time employee and a series of

In 2022, three of the consultants became part time employees of the Company.

During this period, the primary activities

technology evaluation, acquisition and validation, capital acquisition and business development activities which in

general, have readied the Company for contract services while exploring strategic partnering and asset acquisition as noted above.

The Company’s financial statements reflect an accumulated deficit of approximately $4,400,000 as a result of these activities

including the licensing costs for bfLEAP™.

In 2022, the Statement of Operation reflects approximately $2,457,000 in operating

expenses versus $555,000 in the 2021 period.

The increase reflects the Company’s continued preparation for its IPO including

legal and accounting costs related to the audit of the Company’s financial statements including those presented in the

Company’s S-1 filed in connection with the Company’s IPO in February 2023.

The Company also engaged the management team

noted above which resulted in increased consulting and stock-based compensation expenses in 2021 and 2022.

The 2022 Consolidated

Statement of Operations reflects Salaries of approximately $548,000, Consulting and other professional fees of approximately

$644,000 and Stock based compensation of $340,000.

For the 2021 period, these amounts were approximately $203,000, $140,000 and

We anticipate that our general and administrative expenses will increase in the future to support our service offerings,

clinical and pre-clinical research and development activities associated with strategic partnering and collaborations as well as any

newly acquired product candidates and the increased costs of operating as a public company.

These increases will likely include

increased costs related to the hiring of additional personnel and fees to outside consultants, lawyers and accountants, among other

Additionally, we anticipate increased costs associated with being a public company including expenses related to services

associated with maintaining compliance with exchange listing and Securities and Exchange Commission requirements, insurance, and

investor relations costs.

anticipation of the IPO, a management team with deep industry experience was identified and engaged as employees and consultants to assist

the Company in preparing for the IPO and subsequently, to operate and function as a public company.

Through 2022, the primary activities

technology evaluation, acquisition, and validation, capital acquisition and business development activities which in general,

have readied the Company for contract services while exploring strategic partnering and asset acquisition as noted above.

2023, the Company achieved its objective of completing an IPO and listing on NASDAQ.

Our 2023 general and administrative expenses are

significantly higher than our 2022 general and administrative expenses due to several factors.

The primary increases in 2023 relate to

new costs associated with being a public company such as D&O insurance, professional services engaged to support SEC compliance as

well as higher salary and consulting expenses as we have hired additional staff and consultants.

We have also increased our business

development, investor relations and marketing efforts.

We anticipate that our general and administrative expenses may increase in the

future to support our service offerings, clinical and pre-clinical research and development activities associated with strategic partnering

and collaborations.

Growth Company and Smaller Reporting Company Status

Company is an emerging growth company as defined in the Jumpstart Our Business Startups Act of 2012 (“JOBS Act”) and may

take advantage of reduced reporting requirements that are otherwise applicable to public companies.

Section 107 of the JOBS Act exempts

emerging growth companies from being required to comply with new or revised financial accounting standards until private companies are

required to comply with those standards.

We have elected to use the extended transition period to comply with new or revised accounting

This may make it difficult to compare our financial results with the financial results of another public company that is either

not an emerging growth company or is an emerging growth company that has chosen not to take advantage of the extended transition period

exemptions because of the potential differences in accounting standards used.

are also a “smaller reporting company”, meaning that the market value of our stock held by non-affiliates plus the aggregate

amount of gross proceeds to us as a result of the IPO is less than $700 million and our annual revenue was less than $100 million during

the most recently completed fiscal year.

We may continue to be a smaller reporting company if either (i) the market value of our stock

held by non-affiliates is less than $250 million or (ii) our annual revenue was less than $100 million during the most recently completed

fiscal year and the market value of our stock held by non-affiliates is less than $700 million.

If we are a smaller reporting company

at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that

are available to smaller reporting companies.

Specifically, as a smaller reporting company we may choose to present only the two most

recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, similar to emerging growth companies, smaller

reporting companies have reduced disclosure obligations regarding executive compensation.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

a smaller reporting company, this disclosure is not required.

FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

“Index to Consolidated Financial Statements” which appears on page F-1 of this Annual Report on Form 10-K.

CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 7. Management’s Discussion and Analysis