Quarterly Report for Quarter Ending July 31, 2025 (Form 10-Q)

Management's Discussion and Analysis of Financial Condition and Results of Operations.

In the following discussion, "Vitro".," the "Company," "we," "our," and "us" refer to Vitro BioPharma, Inc., and its subsidiaries, as the context requires.

The following discussion analyzes our operating results for the three and nine months ended July 31, 2025 and compares those results to the three and nine months ended July 31, 2024. The discussion below also analyzes our liquidity and capital resources as of July 31, 2025 and material changes in those resources since the October 31, 2024. We suggest that you read the following information in conjunction with our unaudited consolidated financial statements for the three and nine months July 31, 2025 and 2024 contained elsewhere in this Report and our audited consolidated financial statements and Management's Discussion and Analysis of Financial Condition and Results of Operations in our Form 10-K. Further, we encourage you to review the Special Note Regarding Forward-Looking Statements.

Overview

We are an innovative biotechnology company targeting autoimmune diseases and inflammatory disorders, with an ancillary focus in the research services and cosmeceutical fields. With respect to our regenerative medicine business, we are developing novel cellular therapeutic candidates intended to address significant unmet medical needs. In the United States, we are authorized to conduct two clinical trials under two FDA IND applications to assess the safety and efficacy of AlloRx Stem Cell therapy in PTHS and Long COVID and expect to commence those trials in late 2025 pending receipt of sufficient working capital. We generate revenue from our other technologies through a number of other activities, including through the sale of our stem cell products as well as cosmeceuticals through InfiniVive MD, our wholly-owned subsidiary, which helps to alleviate our expenses.

Components of Operating Results

Revenue

We generate revenue primarily from our proprietary products and technologies, including through supplying AlloRx Stem Cells, CAFs, native fibroblasts and other stem cell products and technologies developed by us.

In addition, our acquisitions of InfiniVive MD, and to a lesser extent, Fitore, provide us revenue through sales of topical cosmetic conditioned media and exosomes serums through InfiniVive MD and sales of dietary supplements, nutraceuticals and health products through Fitore. However, we expect that sales of Fitore products in the future will be limited, as we are currently selling such products solely from remaining inventory and with minimal marketing efforts, and do not anticipate manufacturing any additional Fitore products in the foreseeable future or at all. We also terminated the chief executive officer and all other employees of Fitore as of June 2022.

Selling, General and Administrative Expenses

Selling, General and Administrative ("SG&A") expenses consist of salaries and other related costs, stock-based compensation, legal fees relating to corporate matters, other professional fees for accounting, auditing, tax and consulting services, insurance costs, travel expenses, and facility-related expenses.

We expect that our SG&A expenses will increase in the future as we expect to increase our headcount to support increased research and development activities relating to our clinical programs. We also expect to incur increased SG&A expenses associated with being a public company, including costs of accounting, audit, legal, regulatory and tax-related services associated with maintaining compliance with stock exchange and SEC requirements, director and officer insurance costs, and investor and public relations costs.

Research and Development Expenses

All our research and development expenses to date have been incurred in connection with the discovery and development of our research products and product candidates. We expect our research and development expenses to increase significantly for the foreseeable future when we commence clinical trials and advance the pre-clinical and clinical development of our programs, including the conduct of our planned clinical trials.

Research and development expenses consist of personnel-related costs, including salaries, benefits, and non-cash stock-based compensation, external research and development expenses incurred under arrangements with third parties, laboratory supplies, costs to acquire and license technologies aligned with our goal of translating engineered cells to medicines, facility and other allocated expenses, including rent, depreciation, and allocated overhead costs, and other research and development expenses. Where appropriate, we will allocate our third-party research and development expenses on a program-by-program basis.

The successful development of product candidates is highly uncertain and subject to numerous risks and uncertainties.

Accordingly, at this time, we cannot reasonably estimate the nature, timing or costs required to complete the remaining development of any product candidates and to obtain regulatory approval for one or more of these product candidates.

Interest Expense

Interest expense consists of interest expense on our outstanding debt.

Unrealized Gain (Loss) on Derivative/Warrant Liability

Unrealized Gain (Loss) on Derivative/Warrant Liability consists of mark to market gains or losses on our warrant liability.

Going Concern

Our consolidated financial statements contained in this Report have been prepared assuming that we will continue as a going concern, which contemplates the continuity of operations, realization of assets, and liquidation of liabilities in the normal course of business. As reflected in our consolidated financial statements, we have an accumulated deficit as of July 31, 2025 of $43.9 million. We incurred net losses of approximately $5.9 million and $9.9 million during the nine months ended July 31, 2025 and the year ended October 31, 2024, respectively. We used cash in operating activities of $1.8 million and $2.3 million during the nine months ended July 31, 2025 and 2024, respectively. We had a working capital deficit of approximately $14.2 million as of July 31, 2025. These factors raise substantial doubt about our ability to continue as a going concern.

We have commenced the execution of our long-range business plan and efforts to generate additional revenue; however, our current cash position is not sufficient to support our daily operations for the next 12 months. Our ability to continue as a going concern is dependent upon our ability to raise additional funds through debt or equity financings and our ability to further implement our business plan and generate additional revenue.

The consolidated financial statements do not include any adjustments related to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should we be unable to continue as a going concern.

Results of Operations

The following table summarizes our operating results for the three months ended July 31, 2025 and 2024:

		Three Months Ended July 31,
		2025				2024
Product Sales		$	595,143			$	318,109
Product Sales, Related Parties			13,500				1,800
Total Revenue			608,643				319,909
Cost of Goods Sold			(69,612	)			(65,438	)
Gross Profit			539,031				254,471
Selling, General and Administrative Expenses			(1,309,934	)			(1,383,346	)
Research and Development			(119,210	)			(125,628	)
Interest Expense			(859,591	)			(1,950,925	)
Gain on Extinguishment of Debt			-				740,724
Unrealized Gain on Derivative/Warrant Liability			51,166				2,315,624
Net Loss		$	(1,698,538	)		$	(149,080	)

Net Loss

We recorded a net loss of $1,698,538 in the three months ended July 31, 2025, an increase of $1,553,359 from the three months ended July 31, 2024 loss of $149,080, or 1,042%. The increased loss in the three months ended July 31, 2025 was due to a gain on forgiveness of debt and significant unrealized gains on derivative liabilities during the three months ended July 31, 2024 that did not occur during the three months ended July 31, 2025. We expect to continue reporting losses until such time, if ever, we can improve the operation of our newly acquired subsidiaries and/or commercialize one or more of our product candidates and generate sales sufficient to offset our operating costs and expenses and interest expenses.

Product Sales

Total revenue in the three months ended July 31, 2025, increased by $288,734, or 90%, from the three months ended July 31, 2024. The increase is attributable to the factors described below. Our revenue is generated by sales of research products, sales of AlloRx Stem Cells to foreign third-party clinics and medical centers, consulting revenue and sales from our subsidiaries, InfiniVive MD and Fitore, there was no consulting revenue recognized in the three months ended July 31, 2025, or 2024.

During the three months ended July 31, 2025 and 2024, research and development product sales were $88,199 and $72,913, respectively, an increase in the three months ended July 31, 2025 of $15,286, or 21%. The decrease was attributable to biopharmaceutical institutions, university research labs and clinics purchasing more CAFs and native fibroblasts in the three months ended July 31, 2025. CAFs and native fibroblasts are used by such institutions for stem cell research and the development of advanced immunotherapy of cancer, and our sales to such institutions are generally completed on a purchase order basis and without minimum purchase obligations. As a result, sales volumes in a particular period may fluctuate based on the number of research programs then being pursued by such institutions.

Sales of AlloRx Stem Cells to foreign third-party clinics for the three months ended July 31, 2025 and 2024 were $490,960 and $214,839 respectively, an increase of $276,121, or 129%. We expect AlloRx Stem Cell sales internationally to increase over the next year as these products expand into additional foreign third-party clinics and medical centers and our current foreign third-party clinics and medical center customers increase their total monthly patients as international travel continues to pick back up.

Product Sales - Related Parties

Product sales to related parties are sales to the medical practice of Dr. Zamora, our former Chief Executive Officer. Such sales for the three months ended July 31, 2025 and 2024, were $13,500 and $1,800, respectively.

Cost of Goods Sold

Our cost of goods sold during the three months ended July 31, 2025 totaled $69,612 compared to $65,438 during the three months ended July 31, 2024, an increase of $4,174, or 6%, resulting in gross profit of $539,031 and $254,471 for the three months ended July 31, 2025 and 2024, respectively. The gross profit percentages for the three months ended July 31, 2025 and 2024 were 89% and 80%, respectively. Cost of goods sold increased for the three months ended July 31, 2025 and 2024 due to higher sales of product during the three months ended July 31, 2025.

Selling, General and Administrative Expenses

SG&A expenses decreased from $1,383,346 in the three months ended July 31, 2024, to $1,309,934 in the three months ended July 31, 2025. This decrease of $73,412 or 5% was primarily due to a reduction in depreciation expense of $26,748 and a reduction in consulting and legal fees of $52,092.

Research and Development

Research and development expenses for the three months ended July 31, 2025 and 2024 were $119,210 and $125,628, respectively, a decrease of $6,418, or 5%, as the Company continues working to identify additional indications for the study of AlloRx Stem Cell therapy and AlloEx exosome therapy.

Interest Expense

Interest expense for the three months ended July 31, 2025, was $859,591, a decrease of $1,091,334 from the interest expense for the three months ended July 31, 2024 of $1,950,925. This decrease is primarily due to debt discount accretion reductions related to the 2024 Senior Secured Notes, since all of the 2024 notes had reached maturity during 2024. The interest expense related to the remaining debt on our balance sheet of approximately $11.6 million is expected to be all non-cash.

Gain on Extinguishment of Debt

During the three months ended July 31, 2024, the Company extinguished certain debt and issued a new debt instrument in its place. The transactions resulted in a gain on extinguishment of debt of $740,724. There was no comparable gain during the three months ended July 31, 2025.

Unrealized Gain on Derivative/Warrant Liability

During the years ended October 31, 2024 and 2023, we issued 8% Convertible Notes and Senior Secured Notes in the aggregate principal amount of $6,436,350. In February and April of 2025, we issued 2025 Series Senior Secured Notes in the aggregate principal amount of $6,687,500. In May of 2025, we issued 2025 Series Senior Secured Notes in the aggregate principal amount of $406,250. In connection with these notes, the Company recognized a Derivative/Warrant liability. As of July 31, 2025 and 2024, this liability was marked to market, resulting in an unrealized gain (loss) during the three months ended July 31, 2025 and 2024 of $51,166 and $2,315,624, respectively.

The following table summarizes our operating results for the nine months ended July 31, 2025 and 2024:

		Nine Months Ended July 31,
		2025				2024
Product Sales		$	1,538,601			$	1,299,056
Product Sales, Related Parties			31,500				18,000
Total Revenue			1,570,101				1,317,056
Cost of Goods Sold			(297,531	)			(244,802	)
Gross Profit			1,272,570				1,072,254
Selling, General and Administrative Expenses			(4,674,989	)			(5,068,793	)
Research and Development			(415,524	)			(421,552	)
Write-off of Offering Costs			-				(2,656,962	)
Interest Expense			(1,359,244	)			(4,282,853	)
Gain on Forgiveness of Debt			343,938				-
Gain (Loss) on Extinguishment of Debt			(1,235,000	)			740,724
Unrealized Gain on Derivative/Warrant Liability			56,263				2,779,997
Net Loss		$	(6,011,986	)		$	(7,837,185	)

Net Loss

We recorded a net loss of $6,011,986 in the nine months ended July 31, 2025, a decrease of $1,825,199 from the nine months ended July 31, 2024, loss of $7,837,185, or 23%. The decreased loss in the nine months ended July 31, 2025 was due to a write-off of offering costs and accretion on the 2024 Senior Secured Notes that occurred in the nine months ended July 31, 2024 offset by a loss on extinguishment of debt during the nine months ended July 31, 2025. We expect to continue reporting losses until such time, if ever, we can improve the operation of our newly acquired subsidiaries and/or commercialize one or more of our product candidates and generate sales sufficient to offset our operating costs and expenses and interest expenses.

Product Sales

Total revenue in the nine months ended July 31, 2025, increased by $253,045, or 19%, from the nine months ended July 31, 2024. The increase is attributable to the factors described below. Our revenue is generated by sales of research products, sales of AlloRx Stem Cells to foreign third-party clinics and medical centers, consulting revenue and sales from our subsidiaries, InfiniVive MD and Fitore.

During the nine months ended July 31, 2025 and 2024, research and development product sales were $355,238 and $322,870, respectively, an increase in the nine months ended July 31, 2025 of $32,368, or 10%. The increase was attributable to biopharmaceutical institutions, university research labs and clinics purchasing moreCAFs and native fibroblasts in the nine months ended July 31, 2025. CAFs and native fibroblasts are used by such institutions for stem cell research and the development of advanced immunotherapy of cancer, and our sales to such institutions are generally completed on a purchase order basis and without minimum purchase obligations. As a result, sales volumes in a particular period may fluctuate based on the number of research programs then being pursued by such institutions.

Sales of AlloRx Stem Cells to foreign third-party clinics for the nine months ended July 31, 2025 and 2024 were $1,113,085 and $870,712 respectively, an increase of $242,373, or 28%. We expect AlloRx Stem Cell sales internationally to increase over the next year as these products expand into additional foreign third-party clinics and medical centers and our current foreign third-party clinics and medical center customers increase their total monthly patients as international travel continues to pick back up.

Product Sales - Related Parties

Product sales to related parties are sales to the medical practice of Dr. Zamora, our former Chief Executive Officer. Such sales for the nine months ended July 31, 2025 and 2024, were $31,500 and $18,000, respectively.

Cost of Goods Sold

Our cost of goods sold during the nine months ended July 31, 2025 totaled $297,531 compared to $244,802 during the nine months ended July 31, 2024, an increase of $52,729, or 22%, resulting in gross profit of $1,272,570 and $1,072,254 for the nine months ended July 31, 2025 and 2024, respectively. The gross profit percentages for the nine months ended July 31, 2025 and 2024 were 81% and 81%, respectively. Cost of goods sold increased for the nine months ended July 31, 2025 and 2024 due to higher sales of product during the nine months ended July 31, 2025.

Selling, General and Administrative Expenses

SG&A expenses decreased from $5,068,793 in the nine months ended July 31, 2024, to $4,674,989 in the nine months ended July 31, 2025. This decrease of $393,804 or 8% was primarily due to a reduction in consulting fees of $537,024 offset partially by an increase in legal fees of $125,609.

Research and Development

Research and development expenses for the nine months ended July 31, 2025 and 2024 were $415,524 and $421,552, respectively, a decrease of $6,028, or 1%, as the Company continues working to identify additional indications for the study of AlloRx Stem Cell therapy and AlloEx exosome therapy.

Writeoff of Offering Cost

During the nine months ended July 31, 2024, the Company recorded as expense $2,656,962 related to the write off of previously capitalized Deferred Offering Costs. The write off of the deferred costs was related to efforts at an initial public offering that has been abandoned by the Company. There was no comparable expense recorded during the nine months ended July 31, 2025.

Interest Expense

Interest expense for the nine months ended July 31, 2025, was $1,359,244, a decrease of $2,921,903, or 68%, from the interest expense for the nine months ended July 31, 2024 of $4,282,853. This decrease is primarily due to debt discount accretion reductions related to the 2024 Senior Secured Notes, since all of the 2024 notes had reached maturity during 2024. The interest expense related to the remaining debt on our balance sheet of approximately $11.6 million is expected to be all non-cash.

Gain on Forgiveness of Debt

During the nine months ended July 31, 2025, the Company negotiated a settlement of the 2021 Series Convertible Notes Payable, whereby the Company would pay a total of $225,000 over a four month period ending May 1, 2025. The remaining principal balance of $255,000 and all accrued interest totaling $88,938, have been forgiven. The transactions resulted in a gain on forgiveness of debt of $343,938. There were no comparable transactions during the nine months ended July 31, 2024.

Loss on Extinguishment of Debt

During the nine months ended July 31, 2025, the Company negotiated an extension to the July Series 2024 note in return for $245,000 in additional principal and pre-funded warrants valued at $990,000, creating the loss on extinguishment of debt of $1,235,000. During the nine months ended July 31, 2024, the Company extinguished certain debt and issued a new debt instrument in its place. The transactions resulted in a gain on extinguishment of debt of $740,724.

Unrealized Gain on Derivative/Warrant Liability

During the years ended October 31, 2024 and 2023, we issued 8% Convertible Notes and Senior Secured Notes in the aggregate principal amount of $6,436,350. In February and April of 2025, we issued 2025 Series Senior Secured Notes in the aggregate principal amount of $6,687,500. In May of 2025, we issued 2025 Series Senior Secured Notes in the aggregate principal amount of $406,250. In connection with these notes, the Company recognized a Derivative/Warrant liability. As of July 31, 2025 and 2024, this liability was marked to market, resulting in an unrealized gain during the nine months ended July 31, 2025 and 2024 of $56,263 and $2,779,997, respectively.

Liquidity and Capital Resources

Overview

Since our inception, we have incurred significant operating losses. We expect to incur significant expenses and operating losses as we advance the preclinical and clinical development of our programs. We expect that our sales, research and development, and general and administrative costs will increase in connection with conducting additional preclinical studies and clinical trials for our current and future programs and product candidates, expanding our intellectual property portfolio, and providing general and administrative support for our operations. As a result, we will need additional capital to fund our operations for the next twelve months and beyond, which we hope to obtain from additional equity or debt financings, collaborations, licensing arrangements, or other sources.

We currently have no credit facility or other committed sources of capital. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through other third-party funding, collaboration agreements, strategic alliances, licensing arrangements or marketing and distribution arrangements, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financing when needed, we may be required to delay, limit, reduce or terminate our drug development or future commercialization efforts or grant rights to develop and market products or product candidates that we would otherwise prefer to develop and market ourselves.

In order to continue as a going concern, as well as to meet our operational goals, we will need to obtain additional capital in both the short and long term, which we will likely obtain through a variety of means, including through public or private equity, debt financings or other sources, including up-front payments and milestone payments from strategic collaborations. To the extent that we raise additional capital through the sale of convertible debt or equity securities, the ownership interest of our stockholders will be diluted, and the terms may include liquidation or other preferences that adversely affect the rights of our stockholders. Such financing may result in dilution to stockholders, imposition of debt covenants, increased fixed payment obligations or other restrictions that may affect our business. If we raise additional funds through up-front payments or milestone payments pursuant to strategic collaborations with third parties, we may have to relinquish valuable rights to our product candidates, or grant licenses on terms that are not favorable to us. In addition, we may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans.

Working Capital

As of July 31, 2025, we had a working capital deficit of approximately $14.2 million, comprised of current assets of $0.6 million and current liabilities of $14.9 million. The working capital deficit at July 31, 2025, increased approximately $5.1 million from October 31, 2024, our prior fiscal year end. Cash decreased from $0.6 million as of October 31, 2024, to $0.2 million at July 31, 2025.

As a result of our limited working capital position as of July 31, 2025, we continue to rely on cash from outside sources to meet our liquidity requirements. Our need for liquidity and capital in the next 12 months include:

	●	advancing the clinical development of AlloRx Stem Cell therapy for the treatment of several indications;
	●	pursuing the preclinical and clinical development of other current and future research programs and product candidates;
	●	in-license or acquire the rights to other products, product candidates or technologies;
	●	maintain, expand and protect our intellectual property portfolio;

	●	hire additional personnel in research, manufacturing and regulatory and clinical development as well as management personnel;
	●	seek regulatory approval for any product candidates that successfully complete clinical development;
	●	expand our manufacturing capabilities;
	●	expand our operational, financial and management systems and increase personnel, including personnel to support our operations as a public company; and
	●	pay our other administrative expenses.

We may endeavor to raise additional capital through the sale of equity or debt in one or more non-public offerings. We do not anticipate commencing any clinical trials of our AlloRx Stem Cell therapy unless and until we receive substantial additional capital, as costs are estimated to be $4 million to $6 million to commence our contemplated Phase 1/2a clinical trials for PTHS and Long COVID, depending on whether we commence one or both trials.

Our significant contractual cash requirements as of July 31, 2025, primarily include payments for operating and finance lease liabilities and principal and interest on loans. Our current and long-term obligations related to these items are outlined in "Note 6-Lease Obligations," and "Note 7-Debt," of the Notes to our unaudited consolidated financial statements within this Report. Additionally, we may incur purchase obligations in the ordinary course of business that are enforceable and legally binding and enter into enforceable agreements to purchase goods or services that specify all significant terms, including fixed or minimum quantities to be purchased and fixed or estimated prices to be paid at the time of settlement. As of July 31, 2025, we had payments for lease, loan and other known contractual obligations of approximately $11.8 million, of which approximately $9.9 million are payable within 12 months as of July 31, 2025.

Our working capital needs beyond the next 12 months include ongoing general and administrative expenses and research and development expenses, the latter of which are expected to increase if and when we commence one or more of our planned clinical trials. In addition to our long-term debt obligations, our long-term capital requirements also include the cost of adding additional clean rooms for manufacturing, which is estimated to cost approximately $0.3 to $0.5 million depending on the amount of anticipated production increase, available capital and manufacturing demands at that time.

Because of the numerous risks and uncertainties associated with research, development and commercialization of our product candidates, it is difficult to estimate with certainty the amount of our working capital requirements. Our future funding requirements will depend on many factors, including:

	●	the progress, costs and results of our clinical trials for our programs for our cell-based therapies;
	●	the progress, costs and results of additional research and preclinical studies in other research programs we initiate in the future;
	●	the costs and timing of process development and manufacturing scale-up activities associated with our product candidates and other programs we advance through preclinical and clinical development;
	●	our ability to establish and maintain strategic collaborations, licensing or other agreements and the financial terms of such agreements;
	●	the extent to which we in-license or acquire rights to other products, product candidates or technologies; and
	●	the costs and timing of preparing, filing and prosecuting patent applications, maintaining and protecting our intellectual property rights and defending against any intellectual property-related claims.

Cash Flows

The following table summarizes our cash flows for the nine months ended July 31, 2025 and 2024:

		Nine months ended July 31,
		2025				2024
Net Cash Used in Operating Activities		$	(1,800,031	)		$	(2,282,833	)
Net Cash Used in Investing Activities			(66,829	)			(634	)
Net Cash provided by Financing Activities			1,470,581				3,724,801
Beginning Cash Balance			571,360				101,754
Ending Cash Balance		$	175,081			$	1,543,088

Operating Activities

Net cash used in operating activities during the nine months ended July 31, 2025, was $1,800,031, compared to $2,282,833 during the nine months ended July 31, 2024, representing a decrease of $482,802, or 21%. The decrease in cash used in operations was due, in part, to a significant decrease in net loss for the nine months ended July 31, 2025 compared to the nine months ended July 31, 2024.

Investing Activities

Cash used in investing activities during the nine months ended July 31, 2025, was $65,519 in patent costs and $1,310 for acquisition of property and equipment compared to $634 in patent costs in the nine months ended July 31, 2024, representing an increase in cash used of $66,195.

Financing Activities

Cash provided by financing activities during the nine months ended July 31, 2025, was $1,470,581, while cash provided by financing activities during the nine months ended July 31, 2024 was $3,724,801. During the nine months ended July 31, 2025, we issued $400,000 in Series A-1 Convertible Preferred Stock, we issued $7,093,750 in 2025 Series Senior Secured Convertible Notes for net proceeds of $5,675,000, we paid $4,370,000 on the 2024 Series Convertible Notes, we paid $225,000 on the 2021 Series Convertible Notes and made capital lease principal payments of $9,419. During the nine months ended July 31, 2024, we issued $4,718,750 in 2024 Series Senior Secured Convertible Notes and common stock purchase warrants for net proceeds of $3,775,000 million and made capital lease principal payments of $50,199.

Critical Accounting Estimates

Our management's discussion and analysis of our financial condition and results of operations are based on our consolidated financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles (GAAP). The preparation of these consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, and expenses, and the disclosure of contingent assets and liabilities in our consolidated financial statements. On an ongoing basis, we evaluate our estimates and judgments, including those related to stock-based awards and Goodwill and Other Intangible Assets. We base our estimates on historical experience, known trends and events, and various other factors that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

Of our policies, we consider the following the most critical to an understanding of our consolidated financial statements as they require the application of the most subjective and complex judgment, involving critical accounting estimates and assumptions impacting our consolidated financial statements. We have applied our policies and critical accounting estimates consistently across our businesses.

Intangibles

Most of our identifiable intangible assets were recognized as part of business combinations we have executed in prior periods. Our identifiable intangible assets are considered definite life intangible assets and are comprised of, trademarks and trade names, customer relationships and patents. Definite life intangible assets are amortized using the straight-line method over their estimated period of useful life.

Our determination of the fair value of the intangible assets acquired involves the use of significant estimates and assumptions. We believe that the fair value assigned to the assets are based on reasonable assumptions and estimates that a market participant would use. Should conditions differ from management's estimates at the time of the acquisition, including changes in volume or timing to current expectations of future revenue growth rates and forecasted margins, or changes in market factors outside of our control, such as discount rates, material write-downs of intangible assets may be required, which would adversely affect our operating results.

We monitor events and changes in circumstances that could indicate carrying amounts of intangible assets may not be recoverable. We review the carrying amounts of our intangible assets for potential impairment when events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Impairment indicators may include any significant changes in the manner of our use of the assets or the strategy of our overall business, certain reorganization initiatives, significant negative industry or economic trends and significant decline in our share price for a sustained period.

When such events or changes in circumstances occur, we compare the carrying amounts of the asset or assets groups with their respective estimated undiscounted future cash flows. If the asset or assets group are determined to be impaired, an impairment charge is recorded in the amount by which the carrying amount of the asset or assets group exceed their fair value.

As of October 31, 2024, we impaired $196,595 of the InfiniVive intangible assets, leaving a balance of $601,887. The amount was impaired because the carrying value of the intangibles was not supported by future cash flows. As of October 31, 2024 and 2023, we impaired $49,431 and $234,795 of the Fitore intangible assets, leaving a balance of $0 in Fitore. The amounts were impaired because the carrying value of the intangibles was not supported by future cash flows. There was no impairment of intangibles in the three and nine months ended July 31, 2025 and 2024.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q (this "Report") contains forward-looking statements that can involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this Report, including statements regarding our future results of operations and financial position, business strategy, prospective products, product approvals, research and development costs, future revenue, timing and likelihood of success, plans and objectives of management for future operations, future results of anticipated products and prospects, plans and objectives of management are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.

In some cases, you can identify forward-looking statements by terms such as "anticipate," "believe," "contemplate," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," or "would" or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements contained in this Report include, but are not limited to, statements about:

	●	the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results;
	●	the timing of commencement and focus of our ongoing and future preclinical studies and clinical trials, and the reporting of data from those studies and trials;
	●	our expectations with regard to the results of our clinical studies, preclinical studies and research and development programs, including the timing for enrollment and the timing and availability of data from such studies;
	●	the size of the market opportunity for our product candidates, including our estimates of the number of patients who suffer from the diseases we are targeting;
	●	our expectations with regard to the timing of submission of an amended request for orphan drug designation ("ODD") and the eligibility of Pitt-Hopkins or any other indications to qualify for ODD or any other regulatory incentives;
	●	our expectations with respect to entry into clinical trial agreements and other agreements with contract research organizations ("CROs"), potential collaborators and clinical trial sites for our preclinical studies and clinical trials;

	●	our ability to acquire, discover, develop and advance product candidates into, and successfully complete, clinical trials;
	●	developments and projections relating to our competitors and our industry and the success of competing therapies that are or may become available;
	●	the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates;
	●	our ability to obtain and maintain regulatory approval of our product candidates;
	●	our plans relating to the further development and commercialization of our product candidates, including additional disease states or indications we may pursue;
	●	our expectations regarding future sales of our other products, including MSC-Gro, and future consulting revenues;
	●	our expectations regarding our ability to renew our agreement with European Wellness and to collect amounts believed to be owed to us for work already completed under our JOA with European Wellness, which expired on July 31, 2023;
	●	the potential effects of public health crises, such as the COVID-19 pandemic, on our preclinical and clinical programs and business;
	●	existing regulations and regulatory developments in the United States and other jurisdictions;
	●	our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and our ability to avoid infringing the intellectual property rights of others;
	●	our ability to effectively manage our growth, including the need to hire additional personnel and our ability to attract, recruit and retain such personnel, and maintain our culture;
	●	our ability to fund the acquisition of fully automated closed system bioprocessing and other equipment and for the development of a new current Good Manufacturing Practices compliant manufacturing facility we expect to lease;
	●	our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;
	●	our plans and ability to obtain funding for our operations, including funding necessary to develop, manufacture and commercialize our product candidates, and to continue as a going concern;
	●	the performance of our third-party suppliers, CROs and manufacturers;
	●	our financial performance; and
	●	the period over which we estimate our existing cash will be sufficient to fund our future operating expenses and capital expenditure requirements.

We have based these forward-looking statements largely on our current expectations and projections about our business, the industry in which we operate and financial trends that we believe may affect our business, financial condition, results of operations and prospects, and these forward-looking statements are not guarantees of future performance or development. These forward-looking statements speak only as of the date of this Report and are subject to a number of risks, uncertainties and assumptions described in the section titled "Risk Factors" in our Form 10-K. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events or otherwise.

In addition, statements that "we believe" and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and you are cautioned not to unduly rely upon these statements.