What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2024-11-12 compared with 2024-08-13 · 116 added, 99 removed, 203 unchanged (51% of the section changed)

3 unchanged sentences

consolidated financial statements and notes thereto as of and for the year ended December 31, 2023 and the related Management’s

Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in our Amendment No.

1 to the Annual

Report on Form 10-K/A, which was filed with the Securities and Exchange Commission (the “SEC”) on June 11, 2024.

Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in our Annual Report on Form 10-K/A

(Amendment No.

1) for the fiscal year ended December 31, 2023, which was filed with the Securities and Exchange Commission (the “SEC”)

on June 11, 2024.

Regarding Forward-Looking Statements

12 unchanged sentences

These statements are only predictions and involve known and unknown risks, uncertainties and other factors,

including the risks set forth in the section entitled “Risk Factors” in our Annual Report on Form 10-K/A for the fiscal year

ended December 31, 2023, as filed with the SEC on June 11, 2024, any of which may cause our company’s or our industry’s actual

results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance

or achievements expressed or implied in our forward-looking statements.

These risks and factors include, by way of example and without

including the risks set forth in the section entitled “Risk Factors” in our Annual Report on Form 10-K/A (Amendment No.

for the fiscal year ended December 31, 2023, as filed with the SEC on June 11, 2024, any of which may cause our company’s or our

industry’s actual results, levels of activity, performance or achievements to be materially different from any future results,

levels of activity, performance or achievements expressed or implied in our forward-looking statements.

These risks and factors include,

by way of example and without limitation:

ability to obtain financing needed to complete our clinical trials and implement our business plan;

41 unchanged sentences

research applications.

of June 30, 2024, our accumulated deficit was $152,951,151.

We have historically only generated a modest amount of revenue, and our losses

have principally been operating expenses incurred in research and development, marketing and promotional activities in order to commercialize

our products and services, plus costs associated with meeting the requirements of being a public company.

We expect to continue to incur

substantial costs for these activities over at least the next year.

of September 30, 2024, our accumulated deficit was $154,042,567.

We have historically only generated a modest amount of revenue, and

our losses have principally been operating expenses incurred in research and development, marketing and promotional activities in order

to commercialize our products and services, plus costs associated with meeting the requirements of being a public company.

to continue to incur substantial costs for these activities over at least the next year.

develop therapeutic products and medical therapies using cell and tissue protocols, primarily involving adult stem cells.

24 unchanged sentences

and August 2021;

Japanese patents related to the ThermoStem Program were issued in December 2017, June 2021, February 2022 and

Japanese patents related to the ThermoStem Program were issued in December 2017, June 2021, February 2022, June

2023, and July 2024;

Israeli patents related to our ThermoStem Program were issued in October 2019, May 2020, and March 2022;

European patents

related to the ThermoStem Program were issued in April 2020, January 2021, and July 2023 .

European patents related to the ThermoStem Program were issued in April 2020, January 2021, and July 2023 .

have obtained a license for a patented curved needle device that is a needle system designed to deliver cells and/or other therapeutic

19 unchanged sentences

of Operations

of the Three Months Ended June 30, 2024 to the Three Months Ended June 30, 2023

financial results for the three months ended June 30, 2024 are summarized as follows in comparison to the three months ended June 30,

of the Three Months Ended September 30, 2024 to the Three Months Ended September 30, 2023

financial results for the three months ended September 30, 2024 are summarized as follows in comparison to the three months ended September

For the Three Months Ended

6 unchanged sentences

Loss From Operations

Other (Income) Expense:

Other Income:

Interest income

Change in fair value of derivative liabilities

Total Other Expense

the three months ended June 30, 2024 and 2023, we generated $19,800 and $64,500, respectively, of royalty revenue in connection with

our sublicense agreement with the SCTC primarily due to a decrease in disc procedures which we expect will increase in future periods.

the three months ended June 30, 2024 and 2023, we generated $69,300 and $0, respectively, of cosmetic product sales revenue in connection

with our exclusive supply agreement with Cartessa.

We expect that our product sales revenue will increase in future periods as we execute

on our contract with Cartessa.

Change in fair value of warrant liabilities

Total Other Income

Net (Loss) Income

$ (1,091,416 )

the three months ended September 30, 2024 and 2023, we generated $2,900 and $30,700, respectively, of royalty revenue in connection with

our sublicense agreement with the SCTC.

The decrease was primarily due to a decrease in disc procedures.

the three months ended September 30, 2024 and 2023, we generated $230,700 and $0, respectively, of cosmetic product sales revenue in

connection with our exclusive supply agreement with Cartessa.

and Development

and development expenses include cash and non-cash compensation of (a) our Vice President of Research and Development;

(b) our Scientific

Advisory Board members;

and development expenses include cash compensation of (a) our Vice President of Research and Development;

(b) our Scientific Advisory

Board members;

and (c) laboratory staff and costs related to our brown fat and disc/spine initiatives.

Research and development

expenses are expensed as they are incurred.

For the three months ended June 30, 2024, research and development expenses increased by

$389,291, or 43%, compared to the three months ended June 30, 2023.

Research and development expenses

are expensed as they are incurred.

For the three months ended September 30, 2024, research and development expenses increased by $510,206,

or 63%, as compared to the three months ended September 30, 2023.

The increase was primarily the result of an increase in lab supply

expense of $208,374, an increase in payroll expense of $129,348, an increase in consulting expense of $23,482 and an increase in equipment

deprecation related to new equipment of $20,319.

expense of $246,384, an increase in recruitment costs for our Phase 2 clinical trial of $73,194, an increase in payroll expense of $141,079

and an increase in consulting expense of $12,680.

We expect that our research and development expenses will continue to increase in subsequent

4 unchanged sentences

For the three months ended

June 30, 2024, general and administrative expenses decreased by $1,018,925, or 45%, as compared to the three months ended June 30, 2023,

primarily driven by a decrease in stock-based compensation expense of $1,161,346 related to vesting of awards, partially offset by an

increase in professional fees of approximately $111,711 primarily related to the recent restatement of our historical financial statements.

the three months ended June 30, 2024, interest income was $175,945, compared to interest income of $96,187 for the three months ended

June 30, 2023.

September 30, 2024, general and administrative expenses decreased by $1,142,999, or 49%, as compared to the three months ended September

30, 2023, primarily driven by a decrease in stock-based compensation expense of $1,209,459 related to the vesting of awards, partially

offset by an increase in cash compensation to employees of $40,075 and an increase in professional fees of $11,836 primarily related

to the recent restatement of our historical financial statements.

the three months ended September 30, 2024, interest income was $158,547, as compared to interest income of $61,667 for the three months

ended September 30, 2023.

The change was primarily due to interest and dividend income on the investments held in marketable securities.

the three months ended June 30, 2024 and 2023, other income primarily related to gains from settlements of certain accrued expenses and

realized and unrealized gain on investments.

in Fair Value of Derivative Liabilities

the three months ended June 30, 2024 and 2023, we recognized a loss on the change in fair value of derivative liabilities of $1,736,611

and $2,728,847, respectively, related to the increase in fair value of warrants that are accounted for as derivative liabilities.

of the Six Months Ended June 30, 2024 to the Six Months Ended June 30, 2023

financial results for the six months ended June 30, 2024 are summarized as follows in comparison to the six months ended June 30, 2023:

For the Six Months Ended

income of $83,333 during the three months ended September 30, 2023 consists of funding received under a National Institutes of Health

Small Business Technology Transfer (STTR) Phase 1 grant, offset by related expenses.

There was no grant income received during the three

months ended September 30, 2024.

the three months ended September 30, 2024 and 2023, other income primarily related to gains from settlements of certain accrued expenses

and realized and unrealized gain on investments.

in Fair Value of Warrant Liabilities

the three months ended September 30, 2024 and 2023, we recognized a gain on the change in fair value of warrant liabilities of $1,036,464

and $7,693,753, respectively, related to the decrease in fair value of warrants that are accounted for as warrant liabilities.

of the Nine Months Ended September 30, 2024 to the Nine Months Ended September 30, 2023

financial results for the nine months ended September 30, 2024 are summarized as follows in comparison to the nine months ended September

For the Nine Months Ended

(As Restated)

5 unchanged sentences

Loss From Operations

(12,000,092 )

Other (Income) Expense:

1 unchanged sentence

Gain on exchange of warrants

Change in fair value of derivative liabilities

Change in fair value of warrant liabilities

Total Other (Income) Expense

the six months ended June 30, 2024 and 2023, we generated $54,800 and $95,800, respectively, of royalty revenue in connection with our

sublicense agreement with the SCTC primarily due to a decrease in disc procedures which we expect will increase in future periods.

the six months ended June 30, 2024 and 2023, we generated $69,300 and $0, respectively, of cosmetic product sales revenue in connection

$ (7,343,233 )

$ (8,113,710 )

the nine months ended September 30, 2024 and 2023, we generated $57,700 and $126,500, respectively, of royalty revenue in connection

with our sublicense agreement with the SCTC.

The decrease was primarily due to a decrease in disc procedures.

the nine months ended September 30, 2024 and 2023, we generated $300,000 and $0, respectively, of cosmetic product sales revenue in connection

with our exclusive supply agreement with Cartessa.

We expect that our product sales revenue will increase in future periods as we execute

on our contract with Cartessa.

and Development

and development expenses include cash and non-cash compensation of (a) our Vice President of Research and Development;

(b) our Scientific

Advisory Board members;

and development expenses include cash compensation of (a) our Vice President of Research and Development;

(b) our Scientific Advisory

Board members;

and (c) laboratory staff and costs related to our brown fat and disc/spine initiatives.

Research and development

expenses are expensed as they are incurred.

For the six months ended June 30, 2024, research and development expenses increased by $215,677,

or 10%, compared to the six months ended June 30, 2023.

The increase was primarily the result of increased lab supply expense of $285,883

and increased payroll expense of $145,380, all partially offset by a decrease in bonus expense of $210,878.

We expect that our research

and development expenses will continue to increase in subsequent fiscal periods.

Research and development expenses

are expensed as they are incurred.

For the nine months ended September 30, 2024, research and development expenses increased by $746,035,

or 25%, as compared to the nine months ended September 30, 2023.

The increase was primarily the result of increased lab supply expense

of $532,268 and increased payroll expense of $271,388, all partially offset by a decrease in bonus expense of $196,878.

We expect that

our research and development expenses will continue to increase in subsequent fiscal periods.

and Administrative

1 unchanged sentence

as corporate expenses such as legal and professional fees, investor relations and occupancy-related expenses.

For the six months ended

June 30, 2024, general and administrative expenses decreased by $2,511,457, or 37%, as compared to the six months ended June 30, 2023,

primarily driven by a decrease in stock-based compensation expense of $2,511,470 related to the vesting of awards and a decrease in payroll

expense of $210,981 all partially offset by an increase in professional fees of $176,339 primarily related to the recent restatement

For the nine months ended

September 30, 2024, general and administrative expenses decreased by $3,674,608, or 40%, as compared to the nine months ended September

30, 2023, primarily driven by a decrease in stock-based compensation expense of $3,681,621 related to the vesting of awards and a decrease

in payroll expense of $170,434 all partially offset by an increase in professional fees of $179,273 primarily related to the recent restatement

of our historical financial statements.

the six months ended June 30, 2024, interest income was $338,542, compared to interest income of $114,403 for the six months ended June

the nine months ended September 30, 2024, interest income was $497,089, as compared to interest income of $176,070 for the nine months

ended September 30, 2023.

The change was primarily due to interest and dividend income on the investments held in marketable securities.

(Income) Expense

the six months ended June 30, 2024 and 2023, other (income) expense was primarily related to gains from settlements of certain accrued expenses and

realized and unrealized gain on investments.

income of $83,333 during the nine months ended September 30, 2023 consists of funding received under a National Institutes of Health

Small Business Technology Transfer (STTR) Phase 1 grant, offset by related expenses.

There was no grant income received during the nine

months ended September 30, 2024.

the nine months ended September 30, 2024 and 2023, other income primarily related to gains from settlements of certain accrued expenses

and realized and unrealized gain on investments.

on Exchange of Warrants

the six months ended June 30, 2024, we recognized a gain on exchange of $1,711,698 related to the issuance of warrants and common stock

in exchange for the cancellation of existing warrants.

in Fair Value of Derivative Liabilities

the six months ended June 30, 2024 and 2023, we recognized a loss on the change in fair value of derivative liabilities of $1,873,930

and $4,217,197, respectively, related to the increase in fair value of warrants that are accounted for as derivative liabilities.

the nine months ended September 30, 2024, we recognized a gain on exchange of $1,711,698 related to the issuance of warrants and common

stock in exchange for the cancellation of existing warrants.

in Fair Value of Warrant Liabilities

the nine months ended September 30, 2024, we recognized a loss on the change in fair value of warrant liabilities of $837,466

related to the increase in fair value of warrants that are accounted for as warrant liabilities.

For the nine months ended September

30, 2023, we recognized a gain on the change in fair value of warrant liabilities of $3,476,556 related to the decrease in fair

value of warrants that are accounted for as warrant liabilities.

and Capital Resources

measure our liquidity in a number of ways, including the following:

June 30, 2024

December 31, 2023

September 30,

(As Restated)

5 unchanged sentences

of Additional Funds

upon our accumulated deficit of $152,951,151 as of June 30, 2024, along with our forecast for continued operating losses and our need

for financing to fund our current and contemplated clinical trials, we will eventually require additional equity and/or debt financing

upon our accumulated deficit of $154,042,567 as of September 30, 2024, along with our forecast for continued operating losses and our

need for financing to fund our current and contemplated clinical trials, we will eventually require additional equity and/or debt financing

to continue our operations.

13 unchanged sentences

agreements on unattractive terms.

the six months ended June 30, 2024 and 2023, our sources and uses of cash were as follows:

Six Months Ended June 30,

On November 6, 2024, we entered into an at-the-market offering agreement pursuant to which we have

an ability to issue and sell shares of our common stock up to an aggregate offering price of $3,614,170.

the nine months ended September 30, 2024 and 2023, our sources and uses of cash were as follows:

Nine Months Ended September 30,

(As Restated)

5 unchanged sentences

Net Cash Provided By Financing Activities

cash used in operating activities was $4,182,945 for the six months ended June 30, 2024, primarily due to cash used to fund the net loss

of $6,251,817, adjusted for net non-cash expenses of $2,351,582, and $282,710 of cash used in changes in operating assets and liabilities.

Net cash used in operating activities was $3,662,831 for the six months ended June 30, 2023, primarily

due to cash used to fund the net loss of $12,881,971, adjusted for non-cash expenses of $9,014,104, and $205,036 of cash provided by changes

in operating assets and liabilities.

cash used in investing activities was $1,954,831 for the six months ended June 30, 2024 primarily due to a purchase of marketable securities

which used $12,784,535 of cash and a sale of marketable securities which provided $10,865,000 of cash.

Net cash provided by investing

activities was $3,358,199 for the six months ended June 30, 2023 primarily due to a sale of marketable securities which provided $10,982,932

of cash and a purchase of marketable securities which used $7,535,662 of cash.

cash provided by financing activities was $7,505,646 for the six months ended June 30, 2024 due to net proceeds received in connection

with the exercise and issuance of warrants, compared to $411,701 net cash provided by financing activities for the six months ended June

30, 2023 due to the net proceeds from the at-the-market offering of our Common Stock.

cash used in operating activities was $5,882,501 for the nine months ended September 30, 2024, primarily due to cash used to fund the

net loss of $7,343,233, adjusted for net non-cash expenses of $1,520,670, and $59,938 of cash used in changes in operating assets and

Net cash used in operating activities was $4,842,249 for the nine months ended September 30, 2023, primarily due to cash

used to fund the net loss of $8,113,710, adjusted for non-cash expenses of $2,885,196, and $386,265 of cash provided by changes in operating

assets and liabilities.

cash used in investing activities was $1,018,078 for the nine months ended September 30, 2024 primarily due to a purchase of marketable

securities which used $18,294,566 of cash and a sale of marketable securities which provided $17,370,243 of cash.

Net cash provided by

investing activities was $3,336,841 for the nine months ended September 30, 2023 primarily due to a sale of marketable securities which

provided $18,089,372 of cash and a purchase of marketable securities which used $14,651,512 of cash.

cash provided by financing activities was $7,505,646 for the nine months ended September 30, 2024 due to net proceeds received in connection

with the exercise and issuance of warrants, compared to $2,265,700 net cash provided by financing activities for the nine months ended

September 30, 2023 due to the net proceeds from the at-the-market offering of our common stock.

do not believe that inflation had a material impact on our business, revenues or operating results during the periods presented.

23 unchanged sentences

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-Q

Item 2. Management’s Discussion and Analysis