Quarterly Report for Quarter Ending March 31, 2026 (Form 10-Q)

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

You should read the following discussion of our financial condition and results of operations in conjunction with the condensed consolidated financial statements and the related notes included elsewhere in this Form 10-Q and with our audited consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on April 14, 2026. In addition to our historical condensed consolidated financial information, the following contains forward-looking statements that reflect our plans, estimates, and beliefs. Our actual results could differ materially from those discussed in the forward-looking statements. Factors that could cause or contribute to these differences include those discussed below and elsewhere in this Form 10-Q.

Forward-Looking Statements

This Quarterly Report on Form 10-Q (this "Form 10-Q") contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be covered by the "safe harbor" created by those sections. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as "believe," "expect," "may," "will," "should," "would," "could," "seek," "intend," "plan," "goal," "project," "estimate," "anticipate," "strategy," "future," "likely" or the negative thereof or other variations thereon or other comparable terminology. All statements other than statements of historical facts included in this Form 10-Q regarding our strategies, prospects, financial condition, operations, costs, plans and objectives are forward-looking statements. Examples of forward-looking statements include, but are not limited to, statements we make regarding: expectations for revenues, cash flows and financial performance and the anticipated results of our ongoing development and business strategies.

Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, but are not limited to, the following:

	●	the success, cost and timing of our clinical development of our products, including the progress of, and results from, our preclinical and
	●	clinical trials of StemPrintER products, our discovery programs and other potential product candidates;
	●	our ability to obtain and maintain regulatory approval of our product candidates, and any related restrictions, limitations or warnings in the label of any of our product candidates, if approved;
	●	our ability to compete with companies currently marketing or engaged in the development of treatments for indications that our product candidates are designed to target;
	●	our plans to pursue research and development of other future product candidates;
	●	the potential advantages of our product candidates and those being developed;
	●	the rate and degree of market acceptance and clinical utility of our product candidates;
	●	the success of our collaborations and partnerships with third parties;
	●	our estimates regarding the potential market opportunity for our product candidates;
	●	our sales, marketing and distribution capabilities and strategy;
	●	our ability to establish and maintain arrangements for manufacture of our product candidates;
	●	our intellectual property position;
	●	our expectations related to the use of capital;
	●	the effect of the COVID-19 pandemic, including mitigation efforts and economic effects, on any of the foregoing or other aspects of our business operations, including but not limited to our preclinical studies and future clinical trials;
	●	our estimates regarding expenses, future revenues, capital requirements and needs for additional financing;
	●	the impact of government laws and regulations; and
	●	our competitive position.

The forward-looking statements are based upon management's beliefs and assumptions and are made as of the date of this report. We undertake no obligation to publicly update or revise any forward-looking statements included in this report. You should not place undue reliance on these forward-looking statements.

This report also contains or may contain estimates, projections and other information concerning our industry and our business, including data regarding the estimated size of our markets and their projected growth rates. Information that is based on estimates, forecasts, projections, or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ materially from events and circumstances reflected in this information. Unless otherwise expressly stated, we obtained these industry, business, market and other data from reports, studies and similar data prepared by third parties, industry and general publications, government data and similar sources. In some cases, we do not expressly refer to the sources from which these data are derived.

Unless otherwise stated or the context otherwise requires, the terms "AccuStem" "we," "us," "our" and the "Company" refer collectively to AccuStem and, where appropriate, its subsidiary.

Overview

We are a clinical stage diagnostics company dedicated to improving outcomes and quality of life for the millions of people worldwide who are at risk of or diagnosed with cancer each year. Our plan is to develop and commercialize a suite of novel, high-value diagnostic tests that support decision making along the entire continuum of oncology care. Our focus will be the launch of our proprietary genomic tests, MSC (MicroRNA Signature Classifier) for patients with lung nodules and StemPrintER for patients with early stage breast cancer. We estimate this market opportunity represents more than $6.3 billion in annual revenue in the US, where we will focus our initial commercialization efforts.

The MSC test, a 24-micro RNA (miRNA) assay was designed to help determine whether lung nodules identified by imaging e.g. LDCT screening (low dose computer tomography screening) are benign or malignant. The test was designed to minimize overtreatment and undertreatment of the 1.6 million patients diagnosed with lung nodules each year in the US, while simultaneously reducing costs to the healthcare system by improving the accuracy of LDCT alone. MSC has been validated in multiple prospective, randomized cohorts representing over 5,000 patients and published in top tier journals including the Journal of Clinical Oncology.

StemPrintER, a 20-gene prognostic assay intended to predict the risk of distant recurrence ("DR") in luminal (ER+/HER2-negative) breast cancer patients. The assay was developed to measure the "stemness" of tumors, or how much a tumor behaves like stem cells which could indicate how likely a cancer is to recur or be resistant to standard treatments, ultimately impacting how patients are managed by their multi-disciplinary care team. StemPrintER has been validated in more than 3,000 patients across multiple clinical cohorts including the TransATAC study. Together, these data confirm that StemPrintER is highly prognostic for outcomes in patients with breast cancer and indicate the potential utility of the test in the oncology clinic.

Beyond our initial plans for MSC and StemPrintER, we believe there is significant opportunity to expand our product portfolio. First, given the broad applicability of tumor "stemness", which has been evaluated in a multitude of different cancers, we believe the StemPrint platform will have meaningful clinical utility beyond breast cancer. As such, we will seek to validate and commercialize StemPrint for a variety of different tumor types. In addition, we plan to offer ancillary commodity testing (e.g., hereditary genetic testing, somatic mutation testing) that augments our proprietary assays and provides additional information and value to patients and physicians throughout the patient care continuum.

We plan to launch our lead product candidate, the microRNA Signature Classifier (MSC) test, for clinical use in early 2027.

MicroRNA Signature Classifier (MSC) Lung Test

Each year, nearly 2.5 million people are diagnosed with lung cancer worldwide. Historically, lung cancer has been identified at later stages where cure is not possible. To improve outcomes for patients, low dose computed tomography (LDCT) screening programs have been implemented in some countries to detect lung cancer earlier. While these programs have been endorsed by medical societies, they have also led to a significant increase in the detection of lung nodules creating a clinical dilemma for patients and their physicians. Most patients with a lung nodule will not have cancer but in most cases clinical factors alone are not sufficient to determine which nodules require further intervention (e.g., biopsy) versus surveillance. In order to facilitate more efficient and effective patient care, genomics, and tests like MSC, have been proposed as a means of supporting the decision-making process regarding the ideal care path for patients with lung nodules.

MSC was designed to interrogate miRNA's given their fundamental role in biological processes as well as their ubiquity within many bodily fluids. In fact, more recent research has shown they are powerful biomarkers for the early detection of imperceptible or asymptomatic cancers.¹ MSC evaluates blood samples collected from patients using a robust real-time quantitative reverse transcription polymerase chain reaction (qRT-PCR) platform.

Our plan is to commercialize MSC for the 1.6 million patients diagnosed with lung nodules in the US each year, translating to a serviceable market opportunity of more than $5.5 billion.

StemPrintER Breast Cancer Risk of Recurrence Test

Each year, more than two million women are diagnosed with breast cancer worldwide. Endocrine receptor positive (ER+) breast cancers constitute the majority of breast cancer cases (~75%) and display remarkable variability in clinical behavior. This heterogeneity makes prognosis and therapy response often challenging to predict using the standard clinicopathological features of the tumor. Although the overall prognosis for this group of patients is good, a significant proportion (~20%) of these patients will experience distant recurrence in the first ten years post-surgery.

StemPrintER, a 20-gene prognostic assay intended to predict the risk of distant recurrence ("DR") in luminal (ER+/HER2-negative) breast cancer patients. StemPrintER has been validated in several clinical cohorts and studies, the largest of which are a consecutive series of approximately 2,400 patients from the European Institute of Oncology ("IEO") and approximately 800 patients from the TransATAC study. StemPrintER evaluates formalin-fixe, paraffin-embedded (FFPE) tissue samples collected from patients using a robust real-time quantitative reverse transcription polymerase chain reaction (qRT-PCR) platform.

With additional research into StemPrintER's ability to predict surgical/radiation treatment benefit, our plan is to commercialize the test for the ~200,000 patients diagnosed with ER+/HER2- breast cancer in the US each year, translating to a serviceable market opportunity of more than $800 million. Given the broad applicability of tumor "stemness", which has been evaluated in a multitude of different cancers, we believe the StemPrint platform will have meaningful clinical utility beyond breast cancer. As such, we will seek to validate and commercialize StemPrint in a variety of different tumor types. Each tumor type, where applicable, would also include ancillary testing to boost our value proposition to customers.

Commercialization of MSC and StemPrintER

In order to commercialize a proprietary genomic classifier, it must meet two important benchmarks- the test must have sufficient data to be used in the clinical management of patients and have enough peer reviewed publications to obtain reimbursement from CMS and other payers. With our four publications in top-tier scientific journals, we believe MSC has met the minimum threshold to enable commercialization. Thus, we plan to launch MSC once we have achieved several key milestones. The first- identifying or building a laboratory that will be responsible for processing, testing and reporting MSC results for all commercial samples- has been achieved by partnering with a commercial laboratory, EmeritusDx, located in Lake Forest, CA. The next milestone, transferring MSC from the laboratory in which it was developed to a commercial laboratory in the US, is actively under way. Finally, once testing is established in that partner laboratory, we will seek to obtain U.S. Clinical Laboratory Improvement Amendments of 1988 ("CLIA") certification so that we are able to report results for clinical use and to seek reimbursement from the Centers for Medicare and Medicaid Services. We anticipate that it will take at least 18 months to complete these milestones. Once those tasks are complete, we plan to initially launch StemPrintER in the US and then expand to other markets as we evaluate clinical need and revenue opportunity. See " - IEO/University of Milan License Agreement" for information regarding the License which could impact our ability to implement our plans.

To augment the value proposition of MSC and StemPrintER, we also plan to offer additional "commodity" testing (e.g., next generation sequencing). These additional tests should create significant value for our customers while leveraging existing laboratory equipment and processes for economy of scale and providing additional revenue opportunities to the Company.

Financial Operations Overview

We have no products approved for commercial sale and have not generated revenue to date. We have never been profitable and have incurred net losses in each year since inception. We incurred net losses of $485,883 and $440,408 for the three months ended March 31, 2026 and 2025, respectively. As of March 31, 2026, we had an accumulated deficit of $10,269,026. Substantially all of our net losses resulted from expenses incurred in connection with our research and development programs and from general and administrative costs associated with our operations.

Segment Information

As of March 31, 2026, we viewed our operations and managed our business as one operating segment consistent with how our chief operating decision maker, our Chief Executive Officer, makes decisions regarding resource allocation and assessing performance. As of March 31, 2025, substantially all of our assets were located in the United States. Our headquarters and operations are located in New York, NY and London, UK.

Results of Operations

The following discussion and analysis of our results of operations includes a comparison of the three months ended March 31, 2026 to the three months ended March 31, 2025:

		Three Months Ended March 31,
		2026				2025				$ Change				% Change
Revenue		$	-			$	-			$	-				-%
Research and development expenses			119,525				28,346				91,179				322	%
General and administrative expenses			366,358				412,062				(45,704	)			(11	%)
Loss from operations			485,883				440,408				45,475				10	%
Loss, before income tax			(485,883	)			(440,408	)			(45,475	)			10	%
Income tax benefit (expense)			-				-				-				-	%
Net loss		$	(485,883	)		$	(440,408	)		$	(45,475	)			10	%

Research and development

Research and development expenses for the three months ended March 31, 2026, increased to $119,525, compared to $28,346 for the three months ended March 31, 2025 primarily due to an increase in MSC related laboratory work and consulting.

General and administrative

General and administrative expenses for three months ended March 31, 2026, decreased to $366,358, compared to $412,062 for the three months ended March 31, 2025 primarily due to no payroll related bonus costs incurred in 2026.

Liquidity and Capital Resources

Sources of Liquidity

Since our inception, we have not generated any revenue and have incurred significant operating losses. Our potential products are at various phases of development. We do not expect to generate significant revenue from product sales for several years, if at all. Pursuant to the demerger, Tiziana transferred $1,353,373 (£1,000,000) in cash in January 2022 to the Company. In addition, subject to the terms of the supplemental demerger agreement, Tiziana invested $2,675,940 (£2,000,000) in cash in March 2022 for additional shares of the Company. Our cash flows may fluctuate and are difficult to forecast and will depend on many factors. As of March 31, 2026, our cash balance is $12,207, which is inadequate for our current planned level of operations.

Cash Flows

The following table summarizes our cash flows:

		For the Three Months Ended March 31,
		2026				2025
Cash flows (used in) provided by operating activities		$	(374,176	)		$	(290,182	)
Cash flows used in investing activities			-				-
Cash flows (used in) provided by financing activities			372,454				321,517
Net (decrease) increase in cash and cash equivalents			(1,722	)			31,335
Cash and cash equivalents at beginning of period			13,929				5,046
Cash and cash equivalents at end of period		$	12,207			$	36,381

Operating Activities

During the three months ended March 31, 2026 and 2025, net cash used in operating activities was primarily the result of net losses, partially offset by prepaid expenses, and accrued expenses.

Investing Activities

There were no cash flows from investing activities during the three months ended March 31, 2026 and 2025.

Financing Activities

During the three months ended March 31, 2026, net cash used in financing activities was primarily due to cash advances from a related party offset by payments on a note payable.

During the three months ended March 31, 2025, net cash used in financing activities was primarily due to cash advances from a related party offset by payments on a note payable.

Market Capital Expenditure Commitments

We have no material commitment for capital expenditures.

Funding Requirements

We expect that our expenses will increase and operating losses will be generated, and we have $10,269,026 of accumulated deficit as at March 31, 2026. Based on our current plans, we believe our existing cash and cash equivalents will be sufficient to fund our operations and capital expenditure requirements until May 2026. We expect to incur substantial additional expenditures in the near term to support our acceleration of activities. We expect to incur net losses for the foreseeable future. Our ability to fund our product development and clinical operations as well as commercialization of our product candidates, will depend on the amount and timing of cash received from planned financings. Our future capital requirements will depend on many factors, including:

	●	the costs, timing and outcomes of clinical trials and regulatory reviews associated with our product candidates;
	●	the costs of commercialization activities, including product marketing, sales and distribution;
	●	the costs of preparing, filing and prosecuting patent applications and maintaining, enforcing and defending intellectual property-related claims;
	●	the emergence of competing technologies and products and other adverse marketing developments;
	●	the effect on our product development activities of actions taken by the FDA, EMA or other regulatory authorities;
	●	our degree of success in commercializing our product candidates, if and when approved; and
	●	the number and types of future products we develop and commercialize.

A change in the outcome of any of these or other variables with respect to the development of any of our product candidates could significantly change the costs and timing associated with the development of that product candidate. Further, our operating plans may change in the future, and we may need additional funds to meet operational needs and capital requirements associated with such operating plans.

Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations through a combination of equity financings, debt financings, collaborations with other companies or other strategic transactions. We do not currently have any committed external source of funds. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a common shareholder . 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 acquisitions or capital expenditures or declaring dividends. If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, 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 financings or other arrangements when needed, we may be required to delay, limit, reduce or terminate our research, product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

Further, our operating plans may change, and we may need additional funds to meet operational needs and capital requirements for clinical trials and other research and development activities. We currently have no credit facility or committed sources of capital. Because of the numerous risks and uncertainties associated with the development and commercialization of our product candidates, we are unable to estimate the amounts of increased capital outlays and operating expenditures associated with our current and anticipated product development programs.

Critical Accounting Policies

There have been no significant changes to our critical accounting policies and estimates from the information provided in Item 7, "Management's Discussion and Analysis of Financial Condition and Results of Operations," included in our Form 10-K for the year ended December 31, 2025.

Off-Balance Sheet Arrangements

We have no other off-balance sheet arrangements that have had, or are reasonably likely to have, a material current or future effect on our consolidated financial statements or changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources.

Recent Accounting Pronouncements

For information on recent accounting pronouncements, see our condensed consolidated financial statements - Note 2 and the related notes found elsewhere in this quarterly report.