ACCUSTEM SCIENCES, INC. Overview
We are a clinical stage diagnostics company dedicated to improving quality of
life and outcomes for the more than 18 million people worldwide who are
diagnosed with cancer each year. Our plan is to develop and commercialize a
suite of novel genomic tests that support decision making along the entire
continuum of oncology care. Our focus will be the commercialization of our
proprietary genomic test, StemPrintER, for patients with early-stage breast
cancer, and we estimate this market opportunity represents more than
Our primary product candidate is 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 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. In the IEO cohort,
StemPrintER High Risk patients ("SPRS High ") were 1.85 times more likely to have
a distant recurrence compared to Low Risk ("SPRS Low") patients (Figure 1) and
in the TransATAC cohort, SPRS High patients were 4.27 times more likely to
experience a distant recurrence compared to SPRS Low Risk patients (Figure 2).
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.
*SPRS- StemPrintER Recurrence Score; SPRS High- StemPrintER High Risk; SPRS Low- StemPrintER Low Risk
Beyond our initial plans for 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. Each tumor type, where applicable, would also include ancillary testing to boost our value proposition to physicians and their patients. 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. -50-
We plan to launch StemPrintER once we have achieved several key milestones. First, we plan to identify or build a laboratory that will be responsible for processing, testing and reporting StemPrintER results for all commercial samples. Further, we plan to transfer the StemPrintER assay from the laboratories in which they were developed to our commercial laboratory. Finally, upon establishing testing capabilities in our commercial laboratory, we will seek to obtainU.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 theCenters 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.
Since our inception, we have devoted substantially all of our resources to conducting research and development of our product candidate. Our revenue is expected to be derived from different sources including standard private third-party and government medical insurance coverage and reimbursement models.
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$3,746,419 and$670,614 for the year endedDecember 31, 2022 and 2021, respectively. As ofDecember 31, 2022 , we had an accumulated deficit of$4,471,281 . 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 ofDecember 31, 2022 , 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 ofDecember 31, 2022 , substantially all of our assets were located inthe United States . Our headquarters and operations are located inNew York, NY andLondon, UK .
Research and development expense
Research and development costs are expensed as incurred. These costs consist of internal and external expenses, as well as depreciation expense on assets used within our research and development activities. Internal expenses include the cost of salaries, benefits, and other related costs, including share-based compensation, for personnel serving in our research and development functions. External expenses include development, clinical trials, patent costs, and regulatory compliance costs incurred with research organizations, contract manufacturers, and other third-party vendors. License fees paid to acquire access to proprietary technology are expensed to research and development, unless it is determined that the technology is expected to have an alternative future use. All patent-related costs incurred in connection with filing and prosecuting patent applications are expensed as incurred to research and development expense due to the uncertainty about the recovery of the expenditure. We record costs for certain development activities, such as preclinical studies and clinical trials, based on our evaluation of the progress to completion of specific tasks. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the consolidated financial statements as prepaid or accrued research and development expense, as applicable. Our recording of costs for certain development activities requires us to use estimates. We believe our estimates and assumptions are reasonable under the current conditions; however, actual results may differ from these estimates. -51-
Research and development expenses account for a significant portion of our operating expenses. We plan to incur research and development expenses for the foreseeable future as we expect to continue the development of our product candidates. We anticipate that our research and development expenses will be higher in fiscal year 2023 and subsequent periods as compared to the prior periods presented herein as we prepare to establish a CLIA certified lab. Our research and development expenses are not currently tracked on a program-by-program basis for indirect and overhead costs. We use our personnel and infrastructure resources across multiple research and development programs directed toward identifying, developing, and commercializing product candidates. At this time, due to the inherently unpredictable nature of preclinical and clinical developments as well as regulatory approval (or authorization) and commercialization, we are unable to estimate with any certainty the costs we will incur and the timelines we will require in our continued development and commercialization efforts. As a result of these uncertainties, successful development and completion of clinical trials as well as regulatory authorization or approval and commercialization are uncertain and may not result in authorized or approved and commercialized products. Completion dates and completion costs can vary significantly for each product candidate and are difficult to predict. We will continue to make determinations as to which product candidates to pursue and how much funding to direct to each product candidate on an ongoing basis in response to our ability to enter into collaborations with respect to each product candidate, the scientific and clinical success of each product candidate as well as ongoing assessments as to the commercial potential of each product candidate.
General and administrative expense
General and administrative expense consists primarily of personnel expenses, including salaries, benefits, insurance, and share-based compensation expense, for employees in executive, accounting, commercialization, human resources, and other administrative functions. General and administrative expense also includes expenses related to pre-commercial activities, corporate facility costs, insurance premiums, legal fees related to corporate matters, and fees for auditing, accounting, and other consulting services. We anticipate that our general and administrative expenses will increase in fiscal year 2023 as compared to the prior periods presented herein as a result of higher corporate infrastructure costs including, but not limited to accounting, legal, human resources, consulting, investor relations, and public company insurance fees. Results of Operations
The following discussion and analysis of our results of operations includes a
comparison of the years ended
December 31, December
2022 31, 2021 $ Change % Change
Revenue $ - $ - $ - - %Research and development expenses 266,933 73,335 193,598 264 % General and administrative expenses 3,479,486 597,279 2,882,207 483 % Loss from operations 3,746,419 670,614 3,075,805 459 % Loss, before income tax (3,746,419 ) (670,614 ) 3,075,805 459 % Income tax benefit (expense) - - - - % Net loss$ (3,746,419 ) $ (670,614 ) $ (3,075,805 ) 459 % -52- Research and development
Research and development expenses increased$193,598 in 2022 as compared to 2021 from$73,335 to$266,933 , primarily due to increases in patent related expenses, and laboratory work and consulting. General and administrative General and administrative expenses increased$2,882,207 in 2022 as compared to 2021 from$597,279 to$3,479,486 , primarily due to increase an increase of payroll related costs as a result of the new management team structure, as well as costs related to legal fees and other compliance expenses.
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 inJanuary 2022 to us. In addition, subject to the terms of the supplemental demerger agreement, Tiziana invested$2,675,940 (£2,000,000) in cash inMarch 2022 for additional shares of the Company. Our cash flows may fluctuate and are difficult to forecast and will depend on many factors. As ofDecember 31, 2022 , our cash balance is$733,978 , which is adequate for our current planned level of operations, through at leastMarch 2023 .
Our cash flows may fluctuate and are difficult to forecast and will depend on many factors.
Cash Flows
The following table summarizes our cash flows:
December 31, 2022 December 31, 2021
Cash flows used in operating activities $ (1,806,053 ) $ -
Cash flows used in investing activities (10,999 ) -
Cash flows from financing activities 2,551,030 -
Net increase in cash and cash equivalents 733,978 -
Cash and cash equivalents at beginning of period - -
Cash and cash equivalents at end of period $ 733,978 $ -
We did not generate any cash flows through
Operating Activities There was an increase in cash flows from operating activities during the year endedDecember 31, 2022 due to the collection of a receivable from a related party. There were no cash flows from operating activities during the year endedDecember 31, 2021 since all cash activities were funded by a related party.
-53- Investing Activities
The cash flow used in investing activities increased during the year ended
Financing Activities We generated cash flows from financing activities during the year endedDecember 31, 2022 due to proceeds from the issuance of common stock to Tiziana, as mentioned in the "Sources of Liquidity" section above. There was no net cash received in financing investing activities for the year endedDecember 31, 2021 .
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 for several years. We have an accumulated deficit of$4,471,281 as ofDecember 31, 2022 . Based on our current plans, we believe our existing cash and cash equivalents will not be sufficient to fund our operations and capital expenditure requirements beyondMarch 2023 . 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 stockholder. 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. -54- 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 Our consolidated financial statements are prepared in accordance with US GAAP. The preparation of our consolidated financial statements and related disclosures requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, costs and expenses, and the disclosure of contingent assets and liabilities in our consolidated financial statements. We base our estimates on historical experience, known trends and events and various other factors that we believe are 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. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.
While our significant accounting policies are described in more detail in our consolidated financial statements, we believe that the following accounting policies are those most critical to the judgments and estimates used in the preparation of our consolidated financial statements.
Share-based Compensation We account for share-based payment awards issued to employees and members of our Board by measuring the fair value of the award on the date of grant and recognizing this fair value as share-based compensation using a straight-line basis over the requisite service period, generally the vesting period. Related parties Parties are related to us if the parties, directly or indirectly, through one or more intermediaries, control, are controlled by, or are under common control with us. Related parties also include our principal owners, our management, members of the immediate families of our principal owners and our management and other parties with which we may deal with if one party controls or can significantly influence the management or operating policies of the other to an extent that one of the transacting parties might be prevented from fully pursuing its own separate interests.
Off-Balance Sheet Arrangements
We have no 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 consolidated financial statements - Note 2 and the related notes found elsewhere in this annual report.
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