What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-11-14 compared with 2025-08-18 · 160 added, 97 removed, 206 unchanged (56% of the section changed)

21 unchanged sentences

Under this agreement, through December 31, 2024, the Company closed on commitments from investors to purchase 625,000 shares of common stock of the Company at $16 per share for total commitments of $10,000,000, which were to be held in escrow until the Company’s registration statement was declared effective.

During the three months ended March 31, 2025, prior to the Company having an effective registration statement, the Company closed on an additional commitment to purchase 102,750 shares of common stock of the Company at $16 per share, for total commitments of $1,644,000, On March 10, 2025, the Company’s registration statement was declared effective at which time the $11,644,000 in escrow was released to the Company.

On March 10, 2025, the Company’s registration statement was declared effective at which time the $11,644,000 in escrow was released to the Company.

On March 26, the Company was listed (“Listing”) on the NASDAQ global markets.

The Company has restated the

previously issued unaudited consolidated financial statements as of and for the quarter ended March 31, 2025 (the “Restatement”).

The Restatement corrects an overstatement of share based compensation due to an incorrect vesting period.

The correction reduced

the share based compensation expense from $23,073,745 to $17,397,774 and the corresponding net loss from $38,002,012 to $32,326,016 for

the quarter ended March 31, 2025.

Investment and Joint Venture

In June 2025, the Company (through a soon to be formed entity – Nuromena Holdings Ltd.

“NuroMena”) entered into a letter of intent to form an investment and joint venture agreement with a Middle-East investor (“Investor”), Quazar Investments.

At the formation date, the Company would own 10 million shares of NuroMena and contribute a license to its technology to NuroMena, and the Investor will purchase 2.5 million shares of NuroMena for a subscription price of $400,000 (“Initial Investment”).

Following the formation of the entity and closing of the Initial Investment, the Investor shall source one or more future investors to purchase up to $50.0 million at $25/share in common stock of the Company, of which 70% of the proceeds will be maintained by the Company and 30% will be transferred to an operating entity to be formed under NuroMena, to conduct clinical trials in the middle-east markets.

As of August 13, 2025, the entity has not yet been formed, and therefore the Initial Investment has not yet occurred.

In June 2025, the Company

(through its recently formed subsidiary – Nuromena Holdings Ltd.

“NuroMena”) entered into a letter of intent to form

an investment and joint venture agreement with a Middle-East investor (“Investor”), Quazar Investments.

At the formation date,

the Company would own 10 million shares of NuroMena and contribute a license to its technology to NuroMena, and the Investor will purchase

2.5 million shares of NuroMena for a subscription price of $400,000 (“Initial Investment”).

Following the formation of the

entity and closing of the Initial Investment, the Investor shall source one or more future investors to purchase up to $50.0 million at

$25/share in common stock of the Company, of which 70% of the proceeds will be maintained by the Company and 30% will be transferred to

an operating entity to be formed under NuroMena, to conduct clinical trials in the middle-east markets.

As of the date of this filing,

the Initial Investment has not yet occurred.

Since its inception, we have

incurred significant operating losses.

Our net loss was $5,680,170 and $4,522,006, for the three months ended June 30, 2025 and

2024, respectively, and $38,006,186 and $7,460,982 for the six months ended June 30, 2025 and 2024, respectively.

We had an accumulated

deficit of $88,614,631 at June 30, 2025.

We expect to continue to incur significant and increasing expenses and operating losses

for the foreseeable future, as we advance our current and future product candidates through preclinical and clinical development, manufacture

drug product and drug supply, seek regulatory approval for our current and future product candidates, maintain and expand our intellectual

property portfolio, hire additional research and development and business personnel and operate as a public company.

Our net loss was $8,615,920 and $2,184,500, for the three months ended September 30, 2025

and 2024, respectively, and $46,622,106 and $9,645,482 for the nine months ended September 30, 2025 and 2024, respectively.

an accumulated deficit of $97,230,551 at September 30, 2025.

We expect to continue to incur significant and increasing expenses and

operating losses for the foreseeable future, as we advance our current and future product candidates through preclinical and clinical

development, manufacture drug product and drug supply, seek regulatory approval for our current and future product candidates, maintain

and expand our intellectual property portfolio, hire additional research and development and business personnel and operate as a public

We will not generate revenue from product sales unless and until we successfully complete clinical development and obtain regulatory approval for our product candidates.

61 unchanged sentences

Amortization on deferred offering costs resulted from the issuance of common stock in connection with a private equity agreement.

Comparison of the three and six months ended June 30, 2025 and 2024:

on Change in Fair Value of Derivative Liability

Loss on change in fair value of derivative liability relates to the

fair value of the discount offered to stockholders who purchased shares under the equity line of credit.

Comparison of the three and nine months

ended September 30, 2025 and 2024:

Results of Operations

1 unchanged sentence

Three Months Ended

September 30,

Cost of Revenues

4 unchanged sentences

Share based compensation

License expense

Total Operating Expenses

1 unchanged sentence

Other Income (Expense):

Interest income

Amortization on debt issuance and deferred offering costs

Other income, net

Interest and other income

Amortization expense

Interest expense - related parties

Loss on extinguishment of Bridge loan - related party

Loss on change in fair value of derivative liability related to sales of common stock through equity line of credit

$ (8,615,920 )

$ (2,184,500 )

Revenue was generated for fees for a “right to try” humanitarian program during 2025 and 2024.

$ (6,431,420 )

No revenue was generated for

fees for a “right to try” humanitarian program during the three months ended September 30, 2025 and 2024.

Research and Development Expenses

1 unchanged sentence

Three Months Ended

September 30,

Research and development costs by project:

Three Months Ended

September 30,

Clinical trial expense

1 unchanged sentence

Total research and development expense

Research and development expenses were $677,332 and $394,484 for the three months ended June 30, 2025 and 2024, respectively.

A portion of these expenses amounting to approximately $145,588 and $165 for the three months ended June 30, 2025 and 2024, respectively, are from the University of Southern California (USC), where Dr.

Research and development expenses

were $715,038 and $956,725 for the three months ended September 30, 2025 and 2024, respectively.

A portion of these expenses amounting

to approximately $12,395 and $416,571 for the three months ended September 30, 2025 and 2024, respectively are from the University

of Southern California (USC), where Dr.

Chen is a member of the faculty.

The total increase of $282,848 was primarily due to:

The addition of clinical trial sites for NEO100’s clinical trial.

The total decrease of $241,686 was primarily due to:

Pre-clinical laboratory work in 2024 was completed, such that there were no such costs in 2025.

The recruitment for NEO212.

The start of the clinical trial for NEO100-03for a Pediatric Indication.

Increased patient recruitment efforts.

Legal and Professional Expenses

and professional expenses were $520,364 and $590,984 for the three months ended June 30, 2025 and 2024, respectively.

decrease of $70,820 was primarily due to the completion of the direct listing process which occurred in the first quarter of

Legal and professional expenses

were $276,378 and $496,803 for the three months ended September 30, 2025 and 2024, respectively.

The decrease of $220,425 was primarily

due to the completion of the direct listing process which occurred in the first quarter of 2025.

General and Administrative Expenses

General and administrative expenses were $984,262 and $289,652 for the three months ended June 30, 2025 and 2024, respectively.

The increase of $694,610 was primary due to a marketing campaign, rent and travel expenses and expense incurred in pursuit of the Middle East deal for which a letter of intent was executed subsequent to June 30, 2025.

General and administrative

expenses were $902,985 and $243,659 for the three months ended September 30, 2025 and 2024, respectively.

The increase of $659,326

was primary due to a marketing campaign, increased employee headcount and resultant compensation and benefits, rent and travel expenses

and expense incurred in pursuit of the Middle East deal.

Share Based Compensation

Share based compensation resulted from the granting of RSUs and is the recognition of the expense from the grant date (which included a catch up period from the original date of issuance of the RSU’s through the Listing Date, due to the removal of the contingency which occurred on the Listing Date) during the three months June 30, 2025.

Share based compensation resulted

from the granting of RSUs and is the recognition of the expense from the grant date (which included a catch up period from the original

date of issuance of the RSU’s through the Listing Date, due to the removal of the contingency which occurred on the Listing Date)

during the three months ended September 30, 2025.

Interest Expense

Interest expense was $48,750 and $1,171,963 for the three months ended June 30, 2025 and 2024, respectively.

The interest for the three months ended June 30, 2025 relates primarily to the accrued interest for a litigation matter.

The OID interest for the three months ended June 30, 2024 relates to the OID for the related party bridge loan that was converted into common stock in June of 2024.

Interest Income

Interest income was $28,725 and $0 for the three months ended June 30, 2025 and 2024, respectively.

The interest income for the three months ended June 30, 2025, relates primarily interest earned on the money market account.

Loss on Extinguishment of Bridge Loan – related part

Loss on Extinguishment of Bridge Loan – related party was $0 and $2,069,923 for the three months ended June 30, 2025 and 2024, respectively.

The loss is related to the loan being converted into common stock in June 2024.

Interest expense was $869,815

and $0 for the three months ended September 30, 2025 and 2024, respectively.

The interest for the three months ended September 30,

2025 relates primarily to the accrued interest for a litigation matter and the accretion of the convertible note payable of $820,794.

Interest and other Income

Interest income was $6,815

and $12,687 for the three months ended September 30, 2025 and 2024, respectively.

The interest income for the three months ended

September 30, 2025 and 2024, relates primarily interest earned on the money market account.

Loss on Change in Fair

Value of Derivative Liability

on change in fair value of derivative liability was $380,162 and $0 for the three months ended September 30, 2025 and 2024, respectively.

The loss on settlement is related to the discount offered investors who purchased shares of common stock under the equity line of credit,

which commenced in July 2025.

Amortization of Debt Issuance and Deferred Offering Costs

The amortization of debt issuance costs was approximately $192,000 and $0 for the three months ended June 30, 2025 and 2024, respectively.

This represents the amortization of the debt issuance costs associated with the warrants issued for the HCWG line of credit, and offering costs relating to the Mast Hill agreement.

The amortization of debt issuance

costs was approximately $438,111 and $0 for the three months ended September 30, 2025 and 2024, respectively.

This represents the

amortization of the debt issuance costs associated with the warrants issued for the HCWG line of credit, offering costs relating to the

Mast Hill agreement and debt issuance cost associated with the convertible promissory notes.

The following table summarizes our results of operations for the periods presented:

Six Months Ended

Nine Months Ended

September 30,

Cost of Revenues

4 unchanged sentences

Share based compensation

License expense

Advisory fees

4 unchanged sentences

Other Income (Expense):

Interest income

Amortization on debt issuance and deferred offering costs

Other income, net

Interest and other income

Amortization expense

Interest expense

Loss on extinguishment of Bridge loan - related party

Loss on settlement of common share purchases

$ (46,622,106 )

4 unchanged sentences

The following table summarizes the components of our research and development expenses for the periods presented:

Six Months Ended

Nine Months Ended

September 30,

Research and development costs by project:

Six Months Ended

Nine Months Ended

September 30,

Clinical trial expense

1 unchanged sentence

Total research and development expense

Research and development expenses were $1,675,554 and $1,009,000 for the six months ended June 30, 2025 and 2024, respectively.

A portion of these expenses amounting to approximately $230,500 and $165 for the six months ended June 30, 2025 and 2024, respectively, are from the University of Southern California (USC), where Dr.

Research and development expenses

were $2,390,592 and $1,965,726 for the nine months ended September 30, 2025 and 2024, respectively.

A portion of these expenses amounting

to approximately $242,895 and $416,736 for the nine months ended September 30, 2025 and 2024, respectively are from the University

of Southern California (USC), where Dr.

Chen is a member of the faculty.

4 unchanged sentences

Increased patient recruitment efforts.

Legal and Professional

Legal and professional expenses

Legal and professional expenses were $1,477,909 and $1,155,338 for the six months ended June 30, 2025 and 2024, respectively.

The increase of 322,571 was primarily due to completion of the direct listing process.

General and Administrative Expenses

General and administrative expenses were $1,833,747 and $705,264 for the six months ended June 30, 2025 and 2024, respectively.

The increase of $1,128,483 was primary due to a marketing campaign, rent and travel expenses.

were $1,754,287 and $1,652,141 for the nine months ended September 30, 2025 and 2024, respectively.

The increase of $102,146 was

primarily due to completion of the direct listing process.

General and Administrative

General and administrative

expenses were $2,736,732 and $973,923 for the nine months ended September 30, 2025 and 2024, respectively.

The increase of $,762,809

was primary due to amarketing campaign, increased employee headcount and resultant compensation and benefits, rent and travel expenses.

Share Based Compensation

Share based compensation resulted

from the granting of RSUs and is the recognition of the expense from the grant date (which included a catch up period from the original

date of issuance of the RSU’s through the Listing Date, due to the removal of the contingency which occurred on the Listing Date)

through September 30, 2025.

The advisory fee was earned on the Listing Date March 26, 2025.

Interest Expense

Interest expense was $357,672 and $2,559,456 for the six months ended June 30, 2025 and 2024, respectively.

The interest for the six months ended June 30, 2025 relates to the short-term loan in March from a related party in the amount of $300,000 and $56,250 interest for a litigation matter.

The OID interest for the six months ended June 30, 2024 relates to the OID for the related party bridge loan that was converted into common stock in June of 2024.

Interest expense was $1,227,487

and $2,559,456 for the nine months ended September 30, 2025 and 2024, respectively.

The interest for the nine months ended September 30,

2025 relates to the short-term loan in March from a related party in the amount of $300,000 and $146,250 interest for a litigation matter,

and the accretion of the convertible note payable of $820,794.

The OID interest for the nine months ended September 30, 2024 relates

to the OID for the related party bridge loan that was converted into common stock in June of 2024.

Amortization of Debt Issuance and Deferred Offering Costs

The amortization of debt issuance costs were $360,200 and $0 for the six months ended June 30, 2025 and 2024, respectively.

This represents the amortization of the warrants issued for the HCWG line of credit and deferred offering costs relating to the Mast Hill agreement.

The amortization of debt issuance

costs was $798,311 and $0 for the nine months ended September 30, 2025 and 2024, respectively.

This represents the amortization of

the warrants issued for the HCWG line of credit and deferred offering costs relating to the Mast Hill agreement.

Loss on Change in Fair

Value of Derivative Liability

on change in fair value of derivative liability was $380,162 and $0 for the three months ended September 2025 and 2024, respectively.

The loss on settlement is related to the discount offered investors who purchased shares of common stock under the equity line of credit,

which commenced in July 2025.

The following table summarizes our cash flow for the periods indicated:

Six Months Ended

Nine Months Ended

September 30,

Net cash provided by (used in):

Operating activities

$ (16,772,777 )

$ (3,259,512 )

$ (13,513,265 )

Financing activities

1 unchanged sentence

Operating Activities

During the six months ended

June 30, 2025, net cash used in operating activities was $10,964,226 consisting primarily of our net loss of $38,006,186, offset

by share based compensation of $20,923,850, accretion of original issue discount of $300,000, amortization of costs of $769,441 and the

accrued advisory fee of $5,882,710.

During the nine months ended

September 30, 2025, net cash used in operating activities was $16,772,777 consisting primarily of our net loss of $46,622,106, offset

by share based compensation of $25,964,096, accretion of original issue discounts of $820,794, amortization of assets of $1,161,331 and

the accrued advisory fee of $3,675,569.

These were offset by decreases in accrued compensation in the amount of $479,775 and prepaid expenses

in the amount of $267,161.

During the six months ended June 30, 2024, net cash used in operating activities was $172,456 consisting primarily of our net loss of $7,460,982 less the non-cash charge of the accretion of the original issue discount on the bridge loan in the amount $2,558,241, less the non-cash charge for the loss on extinguishment of convertible debt of $2,069,923 and an increase in accounts payable of $1,551,272.

During the nine months ended

September 30, 2024, net cash used in operating activities was $3,259,512 consisting primarily of our net loss of $9,645,482 less

the non-cash charge of the accretion of the original issue discount on the bridge loan in the amount $2,558,241, less the non-cash charge

for the loss on extinguishment of convertible debt of $2,069,923 and an increase in accounts payable of $957,162.

Financing Activities

During the six months ended June 30, 2025, cash provided by financing activities was $11,024,372 consisting primarily of the sale of common stock of $11,324,372, receipt of $300,000 from a related party loan and the repayment of related party loan of $600,000.

During the six months ended June 30, 2024, cash used in financing activities was $1,673,148, consisting primarily of proceeds from the sale of common stock of $1,702,658.

During the nine months ended

September 30, 2025, cash provided by financing activities was $18,221,108 consisting primarily of the sale of common stock of $11,324,522,

proceeds from the issuance of the convertible note of $4,000,000 and proceeds from the sales of common stock under the equity line of

credit of $3,196,736.

During the nine months ended

September 30, 2024, cash used in financing activities was $4,562,277, consisting primarily of proceeds from the sale of common stock

of $4,615,789.

Liquidity and Capital Resources

1 unchanged sentence

Since our inception, we have funded our operations through the sale and issuance of preferred and common stock and debt financing rounds from related and third parties.

In March 2025 prior to our direct listing we issued 625,000 shares of common stock in a private placement at a price of $16.00 per share for gross proceeds of approximately $10,000,000.

In March 2025 after our direct listing we issued 102,750 shares of common stock in a private placement at a price of $16.00 per share for gross proceeds of approximately $1,644,000.

No shares of common stock were issued in the quarter ending June 30, 2025.

During the nine months ended

September 30, 2025, the Company sold 727,750 shares of common stock at a price of $16.00 per share for gross proceeds of $11,644,005

pursuant to a private placement of its securities, issued 46,000 shares as part of advisory services related to the listing and as part

of the private placement fee for our equity line of credit, 162,500 shares were issued for the cashless exercise of warrants and issued

447,527 shares from the sale of shares under the equity line of credit,

The accompanying consolidated

financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the settlement of

liabilities and commitments in the normal course of business.

Since our inception, we have not generated any revenue from product sales

or any other sources, except humanitarian use, and we have incurred significant operating losses.

We have not yet commercialized any

products, and we do not expect to generate revenue from sales of any product candidates for a number of years, if ever.

in the accompanying consolidated financial statements, we have incurred recurring net losses since our inception.

For the three and six

months ended June 30, 2025, the Company incurred a net loss of $5,680,170 and $38,006,186, respectively, and had an accumulated

deficit of $88,614,631 at June 30, 2025.

At June 30, 2025, the Company had cash totaling $125,039.

These factors raise substantial

doubt about our ability to continue as a going concern.

Our ability to continue as a going concern is dependent upon our ability to raise

additional funds and implement our strategies, such as executing additional licensing contracts.

The consolidated financial statements

do not include any adjustments that might be necessary if we are unable to continue as a going concern.

financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the settlement of liabilities

and commitments in the normal course of business.

Since our inception, we have not generated any revenue from product sales or any other

sources, except humanitarian use, and we have incurred significant operating losses.

We have not yet commercialized any products, and

we do not expect to generate revenue from sales of any product candidates for a number of years, if ever.

As reflected in the accompanying

consolidated financial statements, we have incurred recurring net losses since our inception.

For the three and nine months ended September 30,

2025, the Company incurred a net loss of $8,615,920 and $46,622,106, respectively, and had an accumulated deficit of $97,230,551 at September 30,

At September 30, 2025, the Company had cash totaling $1,513,224.

These factors raise substantial doubt about our ability to

continue as a going concern.

Our ability to continue as a going concern is dependent upon our ability to raise additional funds and implement

our strategies, such as executing additional licensing contracts.

The consolidated financial statements do not include any adjustments

that might be necessary if we are unable to continue as a going concern.

The ability to continue as a going concern is dependent on us raising additional capital and attaining and maintaining profitable operations in the future to meet our obligations and repay our liabilities arising from normal business operations when they come due.

37 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