ACUT 10-K & 10-Q changes, risk factors and insider trading
Accustem Sciences Inc. · OTC · Pharmaceutical Preparations · CIK 1850767 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
Largest changes
“In March 2025, we acquired the license for the proprietary microRNA Signature Classifier (MSC) test and all historic data, research and know-how for the test from certain secured creditors and interest holders. The terms of the acquisition include the transfer of all rights, title and interest in the intellectual property relating to the MSC test.”see in full comparison
see in full comparisonWe have been a private company with limited accounting personnel to adequately execute our accounting processes and limited supervisory resources with which to address our internal control over financial reporting.As anewlypublic company, we have designed a control environment as required of public companies under the rules and regulations of the SEC. The Company identified a material weakness as of December 31,20242025 over internal controls over financial reporting due to a lack of accounting resources. If we fail to remediate a material weakness, or if we experience material weaknesses in the future or otherwise fail to maintain an effective system of internal controls in the future, we may not be able to accurately or timely report our financial condition or results of operations, which may adversely affect investor confidence in us and, as a result, the value of our common stock.
Our common stock is quoted onsee in full comparisononthe OTC Markets. Trading in stock quoted on the OTC Markets is often thin and characterized by wide fluctuations in trading prices, duedueto many factors that may have little to do with our operations or business prospects. This volatility could depress the market price ofofour common stock for reasons unrelated to operating performance. Moreover, the OTC Markets is not a stock exchange, and trading of securitiessecuritieson the OTC Markets is often more sporadic than the trading of securities listed on a quotation system like NASDAQ or a stock exchangeexchangelike the NYSEMKT.American. Accordingly, shareholders may have difficulty reselling any of their shares and the lack of liquidity may negatively impact our ability to pursue strategic alternatives.
Full comparison: every changed paragraph (5)
In March 2025, we acquired the license for the proprietary microRNA Signature Classifier (MSC) test and all historic data, research and
know-how for the test from certain secured creditors and interest holders. The terms of the acquisition include the transfer of all rights,
title and interest in the intellectual property relating to the MSC test.
As of December 31, 2024,2025, we
had had
twofour full-time employees. As we mature, we expect to expand our full-time employee base and hire more scientists, technicians and
other other
skilled and experienced personnel. Our management may need to divert a disproportionate amount of its attention away from the day-to-day
activities and devote a substantial amount of time toward managing these growth activities. We may not be able to effectively manage the
expansion of our operations, which may result in weaknesses in our infrastructure, operational mistakes, loss of business opportunities,
loss of employees and reduced productivity among remaining employees. Our expected growth could require significant capital expenditures
and may divert financial resources from other projects, such as the development of additional products or technologies. If the management
is unable to effectively manage our growth, our expenses may increase more than expected, the ability to generate and/or grow revenues
could be reduced, and we may not be able to implement our business strategy. Our future financial performance and our ability to commercialize
products and compete effectively will depend, in part, on our ability to effectively manage any future growth.
● an exemption
exemption from the requirement to seek nonbinding advisory votes on executive compensation or golden parachute arrangements.
We have been a private company
with limited accounting personnel to adequately execute our accounting processes and limited supervisory resources with which to address
our internal control over financial reporting. As a newly public company, we have
designed a control environment as required of public
companies under the rules and regulations of the SEC. The Company identified a material
weakness as of December 31, 20242025 over internal
controls over financial reporting due to a lack of accounting resources. If we fail to
remediate a material weakness, or if we experience
material weaknesses in the future or otherwise fail to maintain an effective system
of internal controls in the future, we may not be
able to accurately or timely report our financial condition or results of operations,
which may adversely affect investor confidence in
us and, as a result, the value of our common stock.
Our common stock is quoted
on on
the OTC Markets. Trading in stock quoted on the OTC Markets is often thin and characterized by wide fluctuations in trading prices,
due due
to many factors that may have little to do with our operations or business prospects. This volatility could depress the market price
of of
our common stock for reasons unrelated to operating performance. Moreover, the OTC Markets is not a stock exchange, and trading of
securities securities
on the OTC Markets is often more sporadic than the trading of securities listed on a quotation system like NASDAQ or a stock
exchange exchange
like the NYSE MKT.American. Accordingly, shareholders may have difficulty reselling any of their shares and the lack of liquidity
may negatively
impact our ability to pursue strategic alternatives.
Management's Discussion & Analysis (MD&A)
Largest changes
Research and development expensessee in full comparisondecreasedincreased$1,339$142,690 in20242025 as compared to20232024 from$139,663$138,324 to$138,324,$281,014, primarily due todecreasesincreasedinspendpatentforrelatedtechnologyexpenses,transferand laboratory work and consulting.activities.
“We generated cash flows from financing activities during the year ended December 31, 2025 due to advances from related party of $957,000, offset by payments on a note payable of $97,729. We generated cash flows from financing activities during the year ended December 31, 2024 due to advances from related party of $781,077, offset by payments on a note payable of $133,445.”see in full comparison
“We generated cash flows from financing activities during the year ended December 31, 2024 due to advances from related party of $781,077, offset by payments on a note payable of $133,445. We generated cash flows from financing activities during the year ended December 31, 2023 due to advances from related party of $1,246,757, offset by payments on a note payable of $343,611.”see in full comparison
General and administrative expensessee in full comparisondecreasedincreased $108,304$544,223in20242025 as compared to20232024 from$1,911,001$1,366,778 to$1,366,778,$1,475,082, primarily due toincreaseincreaseda decrease of payroll related costs as a result of a changeactivity inthepublicmanagementrelations,team structure, as well as costs related to legal feestravel and professionalother compliance expenses.fees.
There wassee in full comparisonaandecreaseincrease in cash flows from operating activities during the year ended December 31,2024.2025. The net loss of$1,505,102$1,756,096 was offset by depreciation expense of$3,630,$418, expenses settledsettledin stock of$233,740,$79,000 stock-based compensation expense of$69,718,$88,695, and changes in operating assets and liabilities of$533,948.$737,594.
We are a clinical stage diagnostics company dedicated to improving quality of life and outcomes for thesee in full comparisonmoremillionsthan 18 millionof people worldwide who are diagnosed with or at risk of cancer each year. Our plan is to develop and commercialize a suite of novel genomic tests that support decision making along the entire continuumcontinuumof oncology care. Our focus will be the launch of our proprietary genomic tests, MSC (MicroRNA Signature Classifier) for patients withwithlung nodules and StemPrintER for patients with early stage breast cancer. We estimate this market opportunity represents more than $6.3$6.3billion in annual revenue in the US, where we will focus our initial commercialization efforts.
Full comparison: every changed paragraph (9)
We are a clinical stage diagnostics
company dedicated to improving quality of life and outcomes for the moremillions than 18 millionof people worldwide who are diagnosed with or at risk of
cancer
each year. Our plan is to develop and commercialize a suite of novel genomic tests that support decision making along the entire
continuum continuum
of oncology care. Our focus will be the launch of our proprietary genomic tests, MSC (MicroRNA Signature Classifier) for patients
with with
lung nodules and StemPrintER for patients with early stage breast cancer. We estimate this market opportunity represents more than
$6.3 $6.3
billion in annual revenue in the US, where we will focus our initial commercialization efforts.
We plan to launch MSC and
StemPrintER StemPrintER
once we have achieved several key milestones. The first, identifying or building a laboratory that will be responsible for
processing, processing,
testing and reporting MSC and StemPrintER results for all commercial samples, has been completed with the execution of our
agreement with
EmeritusDx. Further, we plan to transfer the MSC and StemPrintER assays from the laboratories in which they were developed
to our laboratory
partner, EmeritusDx. Finally, upon establishing testing capabilities in our commercial 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 atapproximately least 126 months
to complete
these milestones. Once those tasks are complete, we plan to initially launch MSC and StemPrintER in the US and then expand
to other markets
as we evaluate clinical need and revenue opportunity.
Research and development expenses decreasedincreased $1,339$142,690
in 20242025 as compared to 20232024 from $139,663$138,324 to $138,324,$281,014, primarily due to decreasesincreased inspend patentfor relatedtechnology expenses,transfer and laboratory work and
consulting.activities.
General and administrative expenses decreasedincreased
$108,304 $544,223
in 20242025 as compared to 20232024 from $1,911,001$1,366,778 to $1,366,778,$1,475,082, primarily due to increaseincreased a decrease of payroll related costs as a result of
a changeactivity in thepublic managementrelations, team structure, as well as costs related to legal feestravel and
professional other compliance expenses.fees.
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 us. 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 December 31, 2024,2025, our cash balance is $5,046$13,929 which is not adequate
for our current planned level of operations, through at least AprilJanuary 2025.2026.
There was aan decreaseincrease in cash flows from operating
activities during the year ended December 31, 2024.2025. The net loss of $1,505,102$1,756,096 was offset by depreciation expense of $3,630,$418, expenses settled
settled in stock of $233,740,$79,000 stock-based compensation expense of $69,718,$88,695, and changes in operating assets and liabilities of $533,948.$737,594.
We generated cash flows from financing activities during the year ended December 31, 2025 due to advances from related party of $957,000, offset by payments on a note payable of $97,729. We generated cash flows from financing activities during the year ended December 31, 2024 due to advances from related party of $781,077, offset by payments on a note payable of $133,445.
We generated cash flows from financing activities
during the year ended December 31, 2024 due to advances from related party of $781,077, offset by payments on a note payable of $133,445.
We generated cash flows from financing activities during the year ended December 31, 2023 due to advances from related party of $1,246,757,
offset by payments on a note payable of $343,611.
We expect that our expenses
will will
increase and operating losses will be generated for several years. We have an accumulated deficit of $8,027,047$9,783,143 as of December 31,
2025. 2024.
Based on our current plans, we believe our existing cash and cash equivalents will not be sufficient to fund our operations and
capital capital
expenditure requirements beyond AprilJanuary 2025.2026. 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:
What changed in the latest 10-Q
Risk Factors
There have been no material changes to the risk factors previously disclosed in our Form 10-K for the year ended December 31, 2025.
No wording changes found in this section.
Full comparison: every changed paragraph (0)
Management's Discussion & Analysis (MD&A)
Largest changes
Research and development expenses for the three months endedsee in full comparisonMarchJune31,30, 2026,increaseddecreased to$119,525,$43,712 compared to$28,346$60,204, for the three months endedMarch31,June202530, 2025, primarily due toantimingincreaseofinspendMSCrelatingrelatedtolaboratorytechnologywork and consulting.transfer.
“Research and development expenses for the six months ended June 30, 2026, increased to $163,237 compared to $88,550, for the six months ended June 30, 2025, primarily due to duplicate invoices received from a supplier last quarter, which are offset with credit notes received, reflected in other income.”see in full comparison
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 ofsee in full comparison$485,883$252,573 and$440,408$401,403 for the three months endedMarchJune31,30, 2026 and 2025, respectively. We incurred net losses of $738,456 and $841,811 for the six months ended June 30, 2026 and2025, respectively.2025. As ofMarchJune31,30, 2026, we had an accumulated deficit of$10,269,026.$10,521,599. 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.
“Other Income for the three and six months ended June 30, 2026, increased to $98,400, compared to $0 for the three and six months ended June 30, 2025, due to one-off credits against supplier invoices that were deemed no longer due and payable.”see in full comparison
General and administrative expenses for three and six months endedsee in full comparisonMarchJune31,30, 2026, decreased to$366,358,$307,261 and $673,619, respectively, compared to$412,062$341,199 and $753,261, respectively, for the three and six months endedMarchJune31,30, 2025 primarily due to no payroll related bonus costscostsincurred in 2026.
The following discussion and analysis of our results of operations includes a comparison of the threesee in full comparisonmonthsandended March 31, 2026 to the threesix months endedMarchJune31,30, 2026 to the three and six months ended June 30, 2025:
Full comparison: every changed paragraph (14)
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
$252,573 and $440,408$401,403 for the three months ended MarchJune 31,30, 2026 and
2025, respectively. We incurred net losses of $738,456 and $841,811 for the six months ended June 30, 2026 and 2025, respectively.2025. As of MarchJune 31,30, 2026,
we had an accumulated deficit of
$10,269,026. $10,521,599. 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.
As
of MarchJune 31,30, 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 MarchJune 31,30,
2025,2026, substantially all of our assets were located in the United States. Our headquarters and operations are located in New York, NY
and London, UK.
The
following discussion and analysis of our results of operations includes a comparison of the three monthsand ended March 31, 2026 to the
threesix months ended MarchJune 31,30, 2026
to the three and six months ended June 30, 2025:
Other Income
Other Income for the three and six months ended June 30, 2026, increased to $98,400, compared to $0 for the three and six months ended June 30, 2025, due to one-off credits against supplier invoices that were deemed no longer due and payable.
Research
and development expenses for the three months ended MarchJune 31,30, 2026, increaseddecreased to $119,525,$43,712 compared
to $28,346$60,204, for the three months ended
March 31,June 202530, 2025, primarily due to antiming increaseof inspend MSCrelating relatedto laboratorytechnology work and consulting.transfer.
Research and development expenses for the six months ended June 30, 2026, increased to $163,237 compared to $88,550, for the six months ended June 30, 2025, primarily due to duplicate invoices received from a supplier last quarter, which are offset with credit notes received, reflected in other income.
General
and administrative expenses for three and six months ended MarchJune 31,
30, 2026, decreased to $366,358,$307,261 and $673,619, respectively, compared
to $412,062$341,199 and $753,261, respectively, for the three and six months ended MarchJune 31,30, 2025 primarily due to no payroll related bonus costs
costs incurred in 2026.
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 MarchJune 31,30, 2026, our cash
balance is $12,207,$12,928, which is inadequate for our current planned level of operations.
During
the threesix months ended MarchJune 31,30, 2026 and 2025, net cash used in operating activities was primarily the result of net losses, partially
offset by prepaid expenses, and accrued expenses.
There
were no cash flows from investing activities during the threesix months ended MarchJune 31,30, 2026 and 2025.
During
the threesix months ended MarchJune 31,30, 2026, net cash used in financing activities was primarily due to cash advances from a related partypartially
offset by payments on a note payable.
During
the threesix months ended MarchJune 31,30, 2025, net cash usedprovided inby financing activities was primarily due to cash advances from a related partyparty, partially
offset by payments on a note payable.
We
expect that our expenses will increase and operating losses will
be generated, and we have $10,269,026$10,521,599 of accumulated deficit as at March 31,June
30, 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 MayAugust 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:
ACUT insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 0 filings. Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
No Form 4 stock transactions in this period.
Well-known investors holding ACUT (13F)
None of the 59 investors we track reported a position in their latest 13F.