AccuStem Sciences, Inc. Extends and Broadens Partnership with Instituto Europeo di Oncologia (IEO) Enabling its Strategic Approach to Address Unanswered Clinical Questions in Early Stage Breast Cancer

• StemPrintER outperformed the current market leader, OncotypeDX test, in stratifying patients according to their risk of breast cancer recurrence

London, UK and Phoenix, AZ (July 11, 2023)- AccuStem Sciences, Inc. (OTCQB: ACUT), a clinical stage diagnostics company dedicated to improving outcomes for patients with cancer, signs further agreement with the IEO, one of the most renowned comprehensive cancer centers in Europe. This important milestone will support the company’s strategic vision following positive results from transATAC study where StemPrintER assay outperformed the current market leader in risk of recurrence testing for women with early stage breast cancer.

With the extension of the StemPrintER licensing agreement, originally transferred with all rights and obligations from Tiziana Life Sciences (NASDAQ: TLSA), AccuStem and the IEO have established and refined goals on the timing of commercialization and have broadened the number of regulatory pathways to bring the test to market in the US and abroad. Beyond this agreement, AccuStem intends to work closely with the IEO on additional proprietary cancer assays leveraging StemPrintER technology.

Investigators from the IEO in Milan and The Royal Marsden Hospital in London evaluated a subgroup of patients from the prospective, randomized ATAC trial (TransATAC). The pivotal TransATAC study has been used to evaluate many of the commonly used breast cancer risk scoring assays, including the market leading OncotypeDX. This recent analysis accomplished two important goals for AccuStem’s StemPrintER test:

• Results confirmed that StemPrintER is highly prognostic, with high risk patients up to 4 times as likely to experience a distant recurrence as low risk patients
• StemPrintER outperformed the OncotypeDX test, developed by Exact Sciences (NASDAQ: EXAS), in stratifying patients according to their risk of breast cancer recurrence[1]

“Showing this prognostic performance compared to the market leader in a prospective, randomized trial is a critical milestone for StemPrintER,” said Wendy Blosser, Chief Executive Officer of AccuStem. “These exciting results are not surprising given the novel pathways such as tumor “stemness” that StemPrintER interrogates. We believe that our test will have significant utility beyond indicating risk of recurrence and aim to demonstrate that with our future trials. We look forward to our next steps and leveraging the technology to bring better outcomes to breast cancer patients”

Breast cancer remains a significant health challenge worldwide, and despite advancements in research and treatment options, there are still unanswered questions regarding the identification, prognosis, and management of early-stage breast cancer. AccuStem Sciences recognizes the urgent need to address these gaps in knowledge and is committed to leveraging its cutting-edge technologies and expertise in stem cell research to make a meaningful impact in this field.

AccuStem plans to launch clinical studies to evaluate StemPrintER’s ability to determine the most effective surgical approach for women with early stage invasive breast cancer. This could have significant treatment implications because, beyond clinical factors and patient preference, clinicians do not currently possess tools to determine the most appropriate surgical interventions. To demonstrate StemPrintER’s disruptive predictive capabilities in a global market that sees more than two million new diagnoses each year, AccuStem will partner with leading US and European institutions to obtain these clinical data for presentation and publication.

About AccuStem

AccuStem is a clinical stage diagnostics company dedicated to optimizing outcomes and quality of life for all patients with cancer. We plan to drive innovation in healthcare by offering proprietary molecular testing that addresses unmet clinical needs from cancer screening through treatment and monitoring. By interrogating novel disease pathways, such as tumor “stemness”, we believe our tools will help care teams better understand the biology of each patient’s cancer, leading to more informed decision making. For more information, please visit www.accustem.com.

About Instituto Europeo di Oncologia (IEO)

The Instituto Europeo di Oncologia (IEO) is a leading comprehensive cancer center located in Milan, Italy. Renowned for its excellence in oncology research and patient care, IEO is committed to advancing knowledge in the field of cancer and developing personalized treatment strategies. With a multidisciplinary approach, IEO brings together internationally recognized experts to collaborate on groundbreaking research initiatives, aiming to improve cancer outcomes and quality of life for patients worldwide.

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[1] https://www.ejcancer.com/article/S0959-8049(22)00007-7/fulltext