What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-11-12 compared with 2025-08-12 · 117 added, 96 removed, 210 unchanged (50% of the section changed)

67 unchanged sentences

research applications.

of June 30, 2025, our accumulated deficit was $163,674,777.

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, 2025, our accumulated deficit was $166,713,054.

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.

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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, March 2022, and

European patents related to the ThermoStem Program were issued in April 2020, January 2021, July 2023, and March 2025.

2023, July 2024 and September 2025;

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

2022, and March 2025;

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

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

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have also derived product revenue from our five-year exclusive supply agreement with Cartessa entered into in April 2024.

Common Stock Repurchase Program

16, 2025, our Board of Directors authorized a common stock repurchase program under which we may repurchase up to $2,000,000 of our outstanding

common stock through June 16, 2026.

No repurchases have been made as of June 30, 2025.

Stock Repurchase Program

June 16, 2025, our Board of Directors authorized a common stock repurchase program under which we may repurchase up to $2,000,000 of

our outstanding common stock through June 16, 2026.

No repurchases have been made as of September 30, 2025.

of Operations

of the Three Months Ended June 30, 2025 to the Three Months Ended June 30, 2024

financial results for the three months ended June 30, 2025 are summarized as follows in comparison to the three months ended June 30,

of the Three Months Ended September 30, 2025 to the Three Months Ended September 30, 2024

financial results for the three months ended September 30, 2025 are summarized as follows in comparison to the three months ended September

For the Three Months Ended

September 30,

Cost of goods sold

Operating Expenses:

and development

Research and development

General and administrative

Operating Expenses

From Operations

Other (Expense) Income:

Total Operating Expenses

Loss From Operations

Other Income:

Interest income

Change in fair value of warrant liabilities

Total Other (Expense) Income

Total Other Income

$ (3,038,277 )

$ (1,091,416 )

the three months ended June 30, 2025 and 2024, we generated $3,300 and $19,800, 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 June 30, 2025 and 2024, we generated $300,000 and $69,300, respectively, of cosmetic product sales revenue in

the three months ended September 30, 2025 and 2024, we generated $11,800 and $2,900, respectively, of royalty revenue in connection with

our sublicense agreement with the SCTC.

The increase was primarily due to an increase in disc procedures.

the three months ended September 30, 2025 and 2024, we generated $0 and $230,700, respectively, of cosmetic product sales revenue in

connection with our exclusive supply agreement with Cartessa.

The decrease is primarily related to the timing of orders for this new

developing revenue stream.

and Development

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Research and development expenses are expensed as they are incurred.

For the three months ended June 30, 2025, research and

development expenses increased by $771,882 or 53.1%, as compared to the three months ended June 30, 2024.

The increase was primarily

the result of an increase in recruitment and other costs for our Phase 2 clinical trial of $640,379, an increase in lab supply expense

of $83,768 and an increase in stock-based compensation expense of $38,533, partially offset by a decrease in bonus expense of $30,132.

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

For the three months ended September 30, 2025, research

and development expenses increased by $1,141,387 or 78.5%, as compared to the three months ended September 30, 2024.

The increase was

primarily the result of an increase in recruitment and other costs for our Phase 2 clinical trial of $850,037, an increase in lab supply

expense of $247,664 and an increase in stock-based compensation expense of $42,065 partially offset by a decrease in headcount costs

of $26,025 and a decrease in bonus expense of $17,625.

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

in subsequent fiscal periods.

and Administrative

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For the three months ended

June 30, 2025, general and administrative expenses increased by $276,559, or 25.2%, as compared to the three months ended June 30, 2024,

primarily driven by an increase in consulting expense of $122,777, an increase in stock-based compensation expense of $105,853, and an

increase in payroll of $36,409 all partially offset by a decrease in professional fees of $13,754.

the three months ended June 30, 2025, interest income was $73,915 as compared to interest income of $175,945 for the three months ended

June 30, 2024.

September 30, 2025, general and administrative expenses increased by $66,504, or 6.3%, as compared to the three months ended September

30, 2024, primarily driven by an increase in stock-based compensation expense of $73,623, an increase in payroll of $58,546, and an increase

in consulting expense of $16,655, partially offset by a decrease in professional fees of $79,744.

the three months ended September 30, 2025, interest income was $57,740 as compared to interest income of $158,547 for the three months

ended September 30, 2024.

The change was primarily due to a decrease in interest income from the investments held in marketable securities

the three months ended June 30, 2025, other income was $518, as compared to other income of $911 for the three months ended June 30,

The change was primarily due to a decrease in dividend income from investments held in marketable securities.

due to a lower average balance of the marketable securities during the 2025 period as compared to the 2024 period.

the three months ended September 30, 2025, other income was $930, as compared to other income of $566 for the three months ended September

The change was primarily due to an increase in dividend income from investments held in marketable securities.

in Fair Value of Warrant Liabilities

the three months ended June 30, 2025, we recognized a gain on the change in fair value of warrant liabilities of $574,591, related to

the decrease in fair value of warrants that are accounted for as warrant liabilities.

For the three months ended June 30, 2024, we recognized

a loss on the change in fair value of warrant liabilities of $1,736,611, related to the increase in fair value of warrants that are accounted

for as warrant liabilities.

of the Six Months Ended June 30, 2025 to the Six Months Ended June 30, 2024

financial results for the six months ended June 30, 2025 are summarized as follows in comparison to the six months ended June 30, 2024:

For the Six Months Ended

the three months ended September 30, 2025, we recognized a gain on the change in fair value of warrant liabilities of $612,064, related

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

For the three months ended September 30, 2024,

we recognized a gain on the change in fair value of warrant liabilities of $1,036,464, related to the decrease in fair value of warrants

that are accounted for as warrant liabilities.

of the Nine Months Ended September 30, 2025 to the Nine Months Ended September 30, 2024

financial results for the nine months ended September 30, 2025 are summarized as follows in comparison to the nine months ended September

For the Nine Months Ended

September 30,

Cost of goods sold

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General and administrative

Operating Expenses

Other (Income) Expense:

Total Operating Expenses

Loss From Operations

(11,821,832 )

Other (Expense) Income:

Interest income

Gain on exchange of warrants

in fair value of warrant liabilities

Total Other (Income) Expense

Change in fair value of warrant liabilities

Total Other Income

$ (11,034,339 )

$ (7,343,233 )

the six months ended June 30, 2025 and 2024, we generated $28,300 and $54,800, respectively, of royalty revenue in connection with our

sublicense agreement with the SCTC.

the nine months ended September 30, 2025 and 2024, we generated $40,100 and $57,700, 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 six months ended June 30, 2025 and 2024, we generated $300,000 and $69,300, respectively, of cosmetic product sales revenue in connection

the nine months ended September 30, 2025 and 2024, we generated $300,000 in each period of cosmetic product sales revenue in connection

with our exclusive supply agreement with Cartessa.

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Research and development expenses are expensed as they are incurred.

For the six months ended June 30, 2025, research and development

expenses increased by $1,341,504, or 38.0%, as compared to the six months ended June 30, 2024.

The increase was primarily the result

of an increase in recruitment and other costs for our Phase 2 clinical trial of $1,180,237, an increase in lab supply expense of $190,519,

and an increase in cash compensation to employees of $45,315, partially offset by a decrease in bonus expense of $68,747 and a decrease

in stock-based compensation expense of $48,041.

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

fiscal periods.

For the nine months ended September 30, 2025, research

and development expenses increased by $2,462,738, or 49.2%, as compared to the nine months ended September 30, 2024.

The increase was

primarily the result of an increase in recruitment and other costs for our Phase 2 clinical trial of $2,010,122, an increase in lab supply

expense of $438,183, and an increase in headcount costs of $19,290, partially offset by a decrease in bonus expense of $86,372 and a

decrease in stock-based compensation expense of $5,976.

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

in subsequent fiscal periods.

and Administrative

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

For the six months ended

June 30, 2025, general and administrative expenses increased by $392,310, or 12.4%, as compared to the six months ended June 30, 2024,

primarily driven by an increase in stock-based compensation expense of $173,179 related to the vesting of awards, an increase in consulting

expense of $110,966, an increase in professional fees of $38,844, and an increase in payroll of $32,728.

the six months ended June 30, 2025, interest income was $173,881, as compared to interest income of $338,542 for the six months ended

June 30, 2024.

The change was primarily due to interest income from the investments held in marketable securities.

the six months ended June 30, 2025, other income was $2,406, as compared to other income of $149,932 for the six months ended June 30,

The change was primarily due to a decrease in dividend income from investments held in marketable securities.

For the nine months ended

September 30, 2025, general and administrative expenses increased by $478,967, or 11.4%, as compared to the nine months ended September

30, 2024, primarily driven by an increase in stock-based compensation expense of $246,803 related to the vesting of awards, an increase

in consulting expense of $127,621, and an increase in payroll of $91,274, partially offset by a decrease in professional fees of $20,748.

the nine months ended September 30, 2025, interest income was $231,621, as compared to interest income of $497,089 for the nine months

ended September 30, 2024.

The change was primarily due to a decrease in interest income from the investments held in marketable securities

due to a lower average balance of the marketable securities during the 2025 period as compared to the 2024 period.

the nine months ended September 30, 2025, other income was $3,336, as compared to other income of $150,498 for the nine months ended

September 30, 2024.

The change was primarily due to a one-time payment received in the 2024 period in connection with the development

of our biocosmeceuticals product line.

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.

There was no gain on exchange of warrants for the six months ended June 30, 2025.

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.

There was no gain on exchange of warrants for the nine months ended September

in Fair Value of Warrant Liabilities

the six months ended June 30, 2025 and 2024, we recognized a loss on the change in fair value of warrant liabilities of $59,528 and $1,873,930,

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

the nine months ended September 30, 2025, we recognized a gain on the change in fair value of warrant liabilities of $552,536 related

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

For 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.

and Capital Resources

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

June 30, 2025

September 30, 2025

December 31, 2024

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of Additional Funds

the six months ended June 30, 2025, we had a net loss of $8.0 million and negative cash flows from operations of $5.5 million, and as

of June 30, 2025, we had working capital of $3.9 million.

We anticipate that we will continue to incur net losses and negative cash flows

from operations as we execute our development plans during 2025 and beyond, as well as other potential strategic and business development

Based on these conditions, we believe we may not have sufficient cash for at least twelve months after the issuance date

of the financial statements included in this Quarterly Report which raises substantial doubt about our ability to continue as a going

the nine months ended September 30, 2025, we had a net loss of $11,034,339 and negative cash flows from operations of $8,373,790, and

as of September 30, 2025, we had working capital of $1,271,781.

We anticipate that we will continue to incur net losses and negative

cash flows from operations as we execute our development plans during 2025 and beyond, as well as other potential strategic and business

development initiatives.

Based on these conditions, we believe we may not have sufficient cash for at least twelve months after the issuance

date of the financial statements included in this Quarterly Report which raises substantial doubt about our ability to continue as a

going concern.

operating needs include the planned costs to operate our business, including amounts required to fund our clinical trials, working capital

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agreements on unattractive terms.

the six months ended June 30, 2025 and 2024, our sources and uses of cash were as follows:

Six Months Ended June 30,

the nine months ended September 30, 2025 and 2024, our sources and uses of cash were as follows:

Nine Months Ended Septemer 30,

Net Cash Used In Operating Activities

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Net Increase in Cash

cash used in operating activities was $5,472,653 for the six months ended June 30, 2025, primarily due to cash used to fund the net loss

of $7,996,062, adjusted for net non-cash expenses of $2,465,349, and $58,060 of cash provided by changes in operating assets and liabilities.

Net 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.

cash provided by investing activities was $4,499,158 for the six months ended June 30, 2025 primarily due to a sale of marketable securities

which provided $6,664,238 of cash, offset by a purchase of marketable securities which used $2,128,680 of cash and a purchase of equipment

which used $36,400 of cash.

Net 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, offset by a sale of marketable securities which provided $10,865,000

cash provided by financing activities was $1,980,856 for the six months ended June 30, 2025 due to net proceeds of $1,938,445 received

in connection with the issuance of common stock for the 2024 ATM offering and $42,411 due to the exercise of stock options, compared

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

with the exercise and issuance of warrants.

cash used in operating activities was $8,373,790 for the nine months ended September 30, 2025, primarily due to cash used to fund the

net loss of $11,034,339, adjusted for net non-cash expenses of $2,246,501, and $414,048 of cash provided by changes in operating assets

and liabilities.

Net 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 liabilities.

cash provided by investing activities was $6,496,796 for the nine months ended September 30, 2025 primarily due to a sale of marketable

securities which provided $9,212,343 of cash, offset by a purchase of marketable securities which used $2,679,147 of cash and a purchase

of equipment which used $36,400 of cash.

Net 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 purchase of equipment which used $93,755

of cash, offset by a sale of marketable securities which provided $17,370,243 of cash.

cash provided by financing activities was $1,931,548 for the nine months ended September 30, 2025 due to net proceeds of $1,938,445 received

in connection with the issuance of common stock for the 2024 ATM offering and $42,411 due to the exercise of stock options, partially

offset by deferred offering costs of $49,308, compared to $7,505,646 net cash provided by financing activities for the nine months ended

September 30, 2024 due to net proceeds of $7,528,027 received in connection with the exercise and issuance of warrants, partially offset

by deferred offering costs of $22,381.

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

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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