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 endedDecember 31, 2021 , as filed with theSEC onApril 18, 2022 . 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. Overview We are a clinical stage diagnostic company dedicated to improving quality of life and outcomes for the more than 18 million patients worldwide who are diagnosed with cancer each year. Our plan is to develop and commercialize an array of products in the diagnostics, pharmaceutical and medical device spaces that enable more informed treatment planning and more effective treatment options for patients. Our initial focus is the commercialization of a proprietary genomic platform, Stem Print, for recurrence risk stratification of different types of cancer. The platform was developed to measure the "stemness" of tumors, or how likely a cancer is to recur or be resistant to standard treatments, which could impact how patients are managed by their multi-disciplinary care team. To augment this proprietary offering we also plan to provide ancillary commodity testing (e.g., hereditary genetic testing, somatic mutation testing) to provide additional information and value to patients and physicians through the patient care continuum. Our initial focus will be providing genomic and genetic testing to patients diagnosed with breast and lung cancer. Our primary product candidate is StemPrintER and related assets, 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 theEuropean 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. [[Image Removed]]
*SPRS- StemPrintER Recurrence Score; SPRS High- StemPrintER High Risk; SPRS Low- StemPrintER Low Risk
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 to StemPrintER, our second product candidate is the MicroRNA Signature Classifier (MSC) test which is designed to evaluate 24 microRNA's (miRNA) to help determine whether lung nodules identified by low dose computed tomography (LDCT) screening are benign or malignant. With the increasing utilization of LDCT programs to identify lung cancers earlier, millions of lung nodules are being identified each year [support]. In most cases, clinical factors alone are insufficient to determine which nodules require further intervention (e.g., biopsy) versus surveillance. We believe the MSC test could help triage patients to the most appropriate care path saving healthcare system dollars and providing patients with more confidence in their treatment plan. The blood-based MSC test was validated in a subset of 939 patients from the prospective, randomized MILD study and demonstrated 87% sensitivity, 81% specificity and a 99% negative predictive value for detecting lung cancer. This validation study indicated that MSC has predictive, diagnostic, and prognostic value and could reduce the false-positive rate of LDCT, thus improving the efficacy of lung cancer screening. We plan to launch StemPrintER and MSC testing once we have achieved several key milestones. First, we are planning to build our corporate headquarters inPhoenix, AZ that will also house a clinical laboratory. That laboratory will be responsible for processing, testing and reporting StemPrintER and MSC results for all commercial samples. Further, we plan to transfer the StemPrintER and MSC technologies from the laboratories in which they were developed to our laboratory inPhoenix . Finally, once our laboratory is established, 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. [[Image Removed]] 15
Impact of the COVID-19 Pandemic
In early 2020, an outbreak of the novel strain of coronavirus (COVID-19) emerged globally. As a result, there have been mandates from federal, state and local authorities resulting in an overall decline in economic activity. There have been no material impacts from COVID-19 on the Company's operations for the periods throughJune 30, 2022 . However, it is possible that the pandemic will continue to significantly impact economies worldwide, which could result in adverse effects on the Company's operations. The extent of the impact of COVID-19 on operations, liquidity, financial condition, and results of operations remain uncertain at this time.
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$1,078,226 and$50,537 for the three months endedJune 30, 2022 and 2021, respectively. We incurred net losses of$1,868,760 and$64,410 for the six months endedJune 30, 2022 and 2021, respectively. As ofJune 30, 2022 , we had an accumulated deficit of$2,593,622 . 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 ofJune 30, 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 ofJune 30, 2022 , substantially all of our assets were located inthe United States . Our headquarters and operations are located inNew York, NY andLondon, UK . Results of Operations
The following discussion and analysis of our results of operations includes a comparison of the three and six months endedJune 30, 2022 to the three and six months endedJune 30, 2021 : Three Months Ended June 30 Six Months Ended June 30 2022 2021 $ Change % Change 2022 2021 $ Change % Change
Research and development expenses $ 54,396$ 30,198 $ 24,198 80 %$ 75,539 $ 32,815 $ 42,724 130 % General and administrative expenses 1,023,830 20,339
1,003,491 4934 % 1,793,221 31,595 1,761,626 5576 % Loss from operations 1,078,226 50,537 1,027,689 2034 % 1,868,760 64,410 1,804,350 2801 %
Loss, before income tax (1,078,226 ) (50,537 ) (1,027,689 ) 2034 % (1,868,760 ) (64,410 ) (1,804,350 ) 2801 % Income tax benefit (expense) - -
- 0 % - - - 0 % Net Loss$ (1,078,226 ) $ (50,537 ) $ (1,027,689 ) 2034 %$ (1,868,760 ) $ (64,410 ) $ (1,804,350 ) 2801 % 16 Research and development
Research and development expenses for the three and six months ended
General and administrative
General and administrative expenses for the three and six months endedJune 30, 2022 increased compared to the three and six months endedJune 30, 2021 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 the Company. 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 ofJune 30, 2022 , our cash balance is$1,981,510 , which is adequate for our current planned level of operations, through at leastDecember 2022 .
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