Desmoplastic Small Round Cell Tumor

Elraglusib Demonstrated Anti-Tumor Activity with Two Ongoing Durable Complete Responses and ~62% Disease Control Rate in First 8 Patients with Relapsed/Refractory Ewing and Ewing-related SarcomasEnrollment Ongoing with Topline Data Anticipated in 1H 2025 CHICAGO and FORT WORTH, Texas, Sept. 09, 2024 (GLOBE NEWSWIRE) -- – Actuate Therapeutics, Inc. (NASDAQ: ACTU) (“Actuate” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers through the inhibition of glycogen synthase kinase-3 beta (GSK-3β), provided an update on its Phase 1/2 trial of elraglusib in relapsed/refractory Ewing Sarcoma (r/r EWS). “Ewing sarcoma is a highly metastatic form of sarcoma and the second most prevalent primary malignant tumor in children and adolescents. There are currently no standardized second-line treatments for r/r EWS and the prognosis for these patients remains poor. There is an urgent need for new therapeutic strategies that combine novel targeted therapies with new mechanisms of action and existing chemotherapy regimens of established but limited efficacy,” said Daniel Schmitt, President & Chief Executive Officer of Actuate. “Elraglusib is one of the few novel targeted agents being pursued for the refractory EWS population and continues to show promise as a viable therapeutic option. Early clinical data suggest that the enhanced antitumor activity of chemotherapy observed in multiple preclinical refractory cancer models is translating well into clinical responses.” The ongoing Phase 1/2 Trial (NCT 04239092) is an open-label, multicenter study evaluating the safety and efficacy of elraglusib in pediatric patients with relapsed/refractory malignancies, including EWS and EWS-related pediatric small round cell sarcomas. To date, the study has enrolled 6 patients with relapsed/refractory EWS (>1 remission); one patient with a desmoplastic small round cell tumor (DSRCT), an ultra-rare, highly aggressive pediatric sarcoma; and one patient with a CIC rearrangement. All patients were treated with elraglusib in combination with cyclophosphamide/topotecan. Two patients with recurrent /refractory EWS are experiencing ongoing complete responses (CR), two patients achieved stable disease (SD), and two patients withdrew from the study before their tumor response could be assessed (Table 1). The patient with Desmoplastic Small-Round-Cell Tumor (DSRCT) achieved a partial response (PR) with a 52% reduction in tumor size but withdrew from the study and is now being followed for survival. Table 1. Summary of EWS and other small round cell sarcomas treated in Clinical Study 1902. PatientTumor TypeBest Overall ResponseOS (days)11EWSCR (CT and CMR by PET)Alive OS = 933 days2EWSCR (CMR by PET)Alive OS = 284 days3DSRCTPRAlive OS = 329 days4EWSSDOS = 177 days5EWSSDOS = 272 days6EWSNot Determined.Patient withdrew from the StudyAlive OS = 318 (LTFU)7EWSNot Determined.Patient withdrew from the StudyOS = 89 days8CIC-rearrangementNot Determined.Patient withdrew from the StudyN/A 1 As of most recent follow-up visits May – August 2024 “We are pleased to share our continued, promising progress with elraglusib in r/r EWS,” said Dr. Andrew Mazar, Actuate’s Scientific Co-Founder and Chief Operating Officer. “Although the sample size is small, we are encouraged by the disease stabilization and two ongoing complete responses observed, including one patient with an overall survival of over 2.5 years. These results are considered promising by clinical experts in pediatric oncology, particularly given the significant unmet medical need and lack of therapeutic alternatives in recurrent EWS, and support the continued development of elraglusib in this rare cancer patient population.” The 1902 study remains open only to patients with recurrent EWS, who will be treated with the combination of elraglusib with cyclophosphamide/topotecan. The study will enroll up to 12 total EWS patients to provide additional rationale for moving the elraglusib/cyclophosphamide/topotecan combination into a phase 2 study in patients with recurrent EWS. Actuate plans to meet with the FDA to discuss the design of a phase 2 study and options for accelerating the development path for elraglusib to commercial registration for the treatment of EWS. About Ewing Sarcoma Ewing sarcoma (EWS) is a highly metastatic form of sarcoma that ranks as the second most prevalent primary malignant tumor of childhood and adolescence originating in bone with a peak incidence at the age of 15 years. Approximately 25% of new EWS patients have metastatic disease when first diagnosed, which is the most significant predictor of poor survival. Treatment options for relapsed/refractory metastatic EWS are limited. Despite intensive therapy, recurrent EWS, whether local or with distant metastases, is almost always fatal. While the use of chemotherapy regimens in conjunction with surgery has resulted in the 5-year survival rate increasing from 59 to 78% in children and young adolescents, and from 20 to 60% in adults, to date, no standard treatment has been defined in the relapsed/refractory setting. About Actuate Therapeutics, Inc. Actuate is a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers. Actuate’s lead investigational drug product, elraglusib (a novel GSK-3 inhibitor), targets molecular pathways in cancer that are involved in promoting tumor growth and resistance to conventional cancer drugs such as chemotherapy including several DDR pathways. For more information on the 1902 Study, please visit ClinicalTrial.gov and reference Identifier NCT04239092. Forward-Looking Statements This press release contains forward-looking statements about us, including our clinical trials and development plans, and our industry. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would,” or the negative of these terms or other comparable terminology are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. All statements, other than statements related to present facts or current conditions or of historical facts, contained in this press release are forward-looking statements. Accordingly, these statements involve estimates, assumptions, substantial risks and uncertainties which could cause actual results to differ materially from those expressed in them, including but not limited to that clinical and preclinical drug development involves a lengthy and expensive process with uncertain timelines and outcomes, and results of prior preclinical studies and early clinical trials are not necessarily predictive of future results, and elraglusib may not achieve favorable results in clinical trials or preclinical studies or receive regulatory approval on a timely basis, if at all; that we may not successfully enroll additional patients or establish or advance plans for phase 2 or other development; that elraglusib could be associated with side effects, adverse events or other properties or safety risks, which could delay or preclude regulatory approval, cause us to suspend or discontinue clinical trials or result in other negative consequences; our reliance on third parties to conduct our non-clinical studies and our clinical trials; our reliance on third-party licensors and ability to preserve and protect our intellectual property rights; that we face significant competition from other biotechnology and pharmaceutical companies; and our ability to fund development activities. In addition, any forward-looking statements are qualified in their entirety by reference to the factors discussed under the heading “Risk Factors” in our final prospectus filed with the SEC on August 13, 2024 pursuant to Rule 424(b)(4) under the Securities Act with respect to our Registration Statement on Form S-1 (File No. 333-279734) and other filings with the SEC. You should assume that the information appearing in this press release is accurate as of its date only. Because the risk factors referred to above could cause actual results or outcomes to differ materially from those expressed in any forward-looking statements made by us or on our behalf, you should not place undue reliance on any forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made. New factors emerge from time to time, and it is not possible for us to predict which factors will arise. In addition, we cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Unless legally required, we do not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events. Investor Contact Mike MoyerManaging DirectorLifeSci Advisors, LLCmmoyer@lifesciadvisors.com

SEATTLE--(BUSINESS WIRE)-- Dr. Ching-Hon Pui, Co-Leader, Hematological Malignancies Program, St. Jude, Memphis, TN and 2020 American Cancer Society Medal of Honor Awardee, “I am very impressed with your previous efforts to help my former patient. You provided AVM0703 in a record time (less than 24 hours) to my patient by sending your colleague by plane to hand deliver the medication to St. Jude from Seattle, WA. The drug yielded an amazing response. Even though my patient had very advanced leukemia, AVM0703 helped to control the disease and bridged him to CAR T cells therapy.” This press release features multimedia. View the full release here: A metastatic esophageal adenocarcinoma patient during his 8th AVM0703 infusion. "Overall I have to say AVM0703 has been the only drug used to tackle my throat cancer since my first AVM0703 treatment on Nov 18th Nov 2022. The result has been rewarding with little by way of side effects apart from dull pain emerging 24 hours after treatment periods round cancer infected upper chest area. This pain seems to last approx 3 hours then fades away and sometimes repeats again on the second day after treatment. No doubt this pain is AVM0703 at work, targeting the cancer. Thank you all for your advice and guidance, by putting the wellness back into my health again. Thank you to all at AVM Biotechnology." (Photo: Business Wire) AVM Biotechnology, a clinical stage company actively enrolling Phase 2 for Relapsed/Refractory Non-Hodgkin’s Lymphoma of all subtypes (partially funded by NCI Ph II FastTrak grant 1R44CA272096), today announced that twenty-eight (28) solid tumor and blood cancer patients have been treated with its immunomodulatory drug AVM0703 through Expanded Access (EAP)/Compassionate Use (CUP) programs. Cancers that have been treated include highly relapsed/refractory, some imminently terminal, patients with glioblastoma, metastatic breast cancer (two with advanced bone metastases), metastatic ovarian cancer, metastatic gastric cancer, Hodgkin’s Lymphoma, mixed phenotype acute leukemia, B-ALL, metastatic colon cancer, malignant myxoid spindle cell neoplasm, non-small cell lung cancer, DLBCL with CNS involvement, desmoplastic small round cell tumor, metastatic esophageal adenocarcinoma, prostate cancer, anaplastic T-cell Non-Hodgkin’s Lymphoma and inoperable/chemotherapy ineligible CNS squamous cell carcinoma. Immunomodulatory AVM0703's relatively broad anti-cancer activity is hypothesized to be due to mobilization of a highly active gamma/delta T-cell receptor expressing immune cell, which is programmed to recognize special stress signals produced by most cancer cells but not normal cells. Requests for additional information about immunomodulatory AVM0703 and its relatively broad activity against solid tumors and blood cancers can be made by contacting compassionateuse@avmbiotech.com. “AVM Biotechnology is committed to providing AVM0703 to patients who cannot participate in our enrolling clinical trial. Based on absence of safety concerns and responses reported to date, we believe AVM0703 may provide benefits to all cancer patients who are desperately searching for options. Our team at AVM Biotechnology is dedicated to providing hope to patients and their loved ones.” Theresa Deisher, AVM Biotechnology, Founder and CEO. Requests for Expanded Access in the US must be made by a US licensed physician. Physicians can learn more about the AVM0703 EAP on clinicaltrials.gov and can request access by sending an email to compassionateuse@avmbiotech.com. About AVM0703: AVM0703 is small molecule immunomodulatory drug enrolling Phase 2 trials in US in relapsed/refractory Non-Hodgkin's Lymphoma (NHL) which began enrollment Q3 2023 (partially funded by NCI Ph II FastTrak grant 1R44CA272096). AVM0703 mobilizes a novel endogenous bispecific gamma delta TCR+ invariant TCR+ Natural Killer T-like cell with profound antitumor activity. AVM0703 has shown an absence of safety concerns with side-effects limited to grades 1-3. Clinical responses in the enrolling NHL trial and in FDA-approved expanded access/compassionate use include multiple NHL sub-types and diverse solid tumor types. Responses to AVM0703 are quite rapid, reported from 30 minutes to 14 days after infusion. Preclinical data also demonstrates a significant response against autoreactive lymphocytes in the NOD Type 1 diabetes model (Funded by NIDDK SBIR Ph I grant 1R43DK121634 and NIDDK SBIR Ph II grant 2R44DK121634). Gamma delta TCR+ lymphocytes recognize phosphoantigens expressed by stressed, cancer and infected cells and autoreactive lymphocytes, but not normal cells. Adoptive transfer of AVM0703 induced gamma delta TCR+ immune cells has potent activity against preclinical melanoma (funded by NCI SBIR Ph I grant 1R43CA246896). Additionally, AVM0703 has been shown to have potent neo-adjuvant activity before chemotherapy against immune-resistant, aggressive mouse A20 lymphoma (Funded by NCI SBIR Ph I 1R43_CA271951). Based on its ability to penetrate collagen-encased desmoplastic tumors, AVM0703 has promise as a neoadjuvant prior to chemoimmunotherapy to improve outcomes for metastatic advanced pancreatic cancer patients. About AVM Biotechnology Inc: AVM Biotechnology is a clinical stage company headquartered in Seattle, WA developing immunomodulatory therapies for hematological cancer, infectious and autoimmune diseases. AVM’s pipeline includes a small molecule that triggers blood cell formation to replace transfusions, and an allogeneic γδTCR+invTCR+ NKT-like cell. AVM Biotechnology has been selected after competitive review by the National Cancer Institute (NCI) as one of the showcase companies for the 2023-2024 National Cancer Institute Small Business Innovation Research (SBIR) Investor Initiatives. AVM Biotechnology has been awarded five (5) highly competitive National Institute of Health SBIR grants; 2 Phase 1 grants and 1 Phase 2 grant from NCI, and 1 Phase 1 and 1 Phase 2 grant from NIDDK to prevent and reverse type 1 diabetes. About US Expanded Access Programs: Sometimes called "compassionate use", expanded access is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. Expanded access may be appropriate when all the following apply: Patient has a serious or immediately life-threatening disease or condition. There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition. Patient enrollment in a clinical trial is not possible. Potential patient benefit justifies the potential risks of treatment. Providing the investigational medical product will not interfere with investigational trials that could support a medical product's development or marketing approval for the treatment indication. Investigational drugs, biologics or medical devices have not yet been approved or cleared by FDA and FDA has not found these products to be safe and effective for their specific use. Furthermore, the investigational medical product may, or may not, be effective in the treatment of the condition, and use of the product may cause unexpected serious side effects. About Compassionate Use Programs: In New Zealand, prescribers may be aware that Section 25 of the Medicines Act 1981 permits practitioners to procure for sale or supply any medicine for a particular patient in their care. In addition, Section 29 of the Medicines Act 1981 enables a New Zealand company to obtain and supply an unapproved medicine when authorised by a prescriber. It is the prescriber's responsibility to ensure that they remain cognisant of any safety issues relating to any unapproved medicines they may be prescribing and communicate the risks and benefits to their patients. Medsafe has a number of links on its website that healthcare professionals may find helpful. These links can be found at: Forward Looking Statements: This contains certain statements that constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements do not relate strictly to historical or current facts and they may be accompanied by words such as "could," "would," "may," "potentially," "suggest," "believes," "expects," "should," and similar words or expressions. These forward-looking statements reflect our current views as of the date this is published, and are subject to risks, uncertainties, assumptions, changes in circumstances, and other factors; drug development and commercialization are highly risky and early clinical results in animals or humans may not reflect the full results from later stage or larger scale clinical trials. These forward-looking statements are subject to risks and uncertainties that could cause our actual results, performance, and expectations to differ materially from those expressed or implied by these statements, including statements about: future and ongoing drug development and timing; the applications of drugs to specific diseases; the potential for ongoing preclinical or clinical trial results; FDA or other regulatory findings and approvals; potential market opportunities; and the occurrence of future events or circumstances. There are risks and uncertainties involving and not limited to our ability to progress in our research and development efforts, complete clinical testing, achieve our expected results, commercialize our products, avoid infringement of patents, trademarks and other proprietary rights of third parties, protect products from competition, navigate the political environment, maintain sufficient capital and funding, avoid problems with our manufacturing processes, maintain our operations, and obtain regulatory approval to sell and market the drugs in the United States and elsewhere. The reader should not place any undue reliance on such forward-looking statements. We have no obligation to release publicly the results of any revisions to any of our forward-looking statements to reflect events or circumstances after the date these statements are made or to reflect the occurrence of unanticipated events, except as may be required by law. View source version on businesswire.com: Contacts AVM Biotechnology Theresa Deisher tdeisher@avmbiotech.com Compassionate Use Mia Lor mlor@avmbiotech.com Partnering/Investing Todd Bertsch tbertsch@avmbiotech.com Source: AVM Biotechnology Smart Multimedia Gallery Photo A metastatic esophageal adenocarcinoma patient during his 8th AVM0703 infusion. "Overall I have to say AVM0703 has been the only drug used to tackle my throat cancer since my first AVM0703 treatment on Nov 18th Nov 2022. The result has been rewarding with little by way of side effects apart from dull pain emerging 24 hours after treatment periods round cancer infected upper chest area. This pain seems to last approx 3 hours then fades away and sometimes repeats again on the second day after treatment. No doubt this pain is AVM0703 at work, targeting the cancer. Thank you all for your advice and guidance, by putting the wellness back into my health again. Thank you to all at AVM Biotechnology." (Photo: Business Wire) Logo View this news release and multimedia online at:

TAKOMA PARK, Md.--( BUSINESS WIRE )--The Jerome Canady Research Institute for Advanced and Biological Technological Sciences (JCRI-ABTS) and US Medical Innovations, LLC (USMI) announced significant positive results from the first FDA Phase I IDE (#G190165) clinical trial for cancer using Canady Helios TM Cold Plasma (CHCP) combined with standard surgical resections at the 2023 American Society of Clinical Oncologists (ASCO) Annual Meeting in Chicago, IL (May 31-June 4, 2023). Safety was the primary endpoint; secondary endpoints were the effect on local regional recurrence (LRR), cancer cell death, preservation of surrounding healthy tissue, and patient survival. (ClinicalTrials.gov identifier: NCT04267575) Cancer remains a significant global health challenge, with over 1.9 million new cases and 608,570 cancer-related fatalities in the United States in 2021. Advances in chemotherapy, radiation, surgery, immunotherapy, and molecular targeted therapy regimes have improved survival, but solid tumor resections still have a risk of LRR and a poor five-year survival rate. Surgery is the primary treatment for most solid tumors, but complete removal of cancerous tissue (R0), microscopic tumor cells (R1) or visible tumor (R2) is challenging which can lead to LRR in 5% to 65% of cases. USMI’s Canady Helios Cold Plasma (CHCP) system, a non-thermal (26-30°C) and non-contact Cold Atmospheric Plasma (CAP) jet, offers a promising solution. The three-dimensional bioelectric Plasma Treated Electromagnetic Field (PTEF)™ created by CHCP causes a biophysical phenomenon known as Irreversible Electroporation (IRE), that increases cancer cell membrane permeability to CAP species such as Reactive Oxygen Species (ROS) and Reactive Nitrogen Species (RNS). This process results in cancer cell death while sparing the noncancerous tissue. The JCRI-ABTS research laboratory discovered and patented the process by which CHCP-treated cancer cells undergo histone mRNA oxidation and degradation, leading to the activation of DNA damage response genes and cell death ( link ) 1 . Standard CHCP treatment dosages for 32 cancer cell lines including breast, sarcoma, glioblastoma, melanoma, ovarian, prostate, colorectal, and lung cancers. have been developed in the JCRI-ABTS laboratory. The Clinical Trial was a multi-center, open-label, prospective, and controlled study conducted between March 2020 - April 2021 at Rush University Medical Center (RUMC) in Chicago, IL, USA, and Sheba Medical Center (SMC) in Tel HaShomer, Israel. Molecular biological studies were performed at JCRI-ABTS. Twenty patients ranging from 26-85 years of age undergoing surgery for advanced stage 4 or recurrent solid tumors were enrolled. Patients with preoperative treatments such as neoadjuvant chemotherapy, immunotherapy, radiation, and previous surgery were eligible. Characteristics of Patients Characteristic No. % No. of Patients 20 Sheba Medical Center 5 25 Rush Medical Center 15 75 Age Median 59.5 Range 26-85 Female 10 50 Male 10 50 Ethnicity White 18 90 African American 1 5 Other 1 5 ECOG 1 Performance Status <2 20 100 Cancer types (all metastatic) Adenoid Cystic Carcinoma 1 5 Anal 1 5 Angiosarcoma 1 5 Breast 1 5 Cholangiocarcinoma 1 5 Chordoma 1 5 Colon 2 10 Melanoma 1 5 Mesothelioma 1 5 Non-Small Cell Lung* 3 15 Ovarian 1 5 Renal 1 5 Sarcoma** 4 20 Squamous Cell Carcinoma 1 5 1 ECOG – Eastern Cooperative Oncology Group * Two Carcinomas and 1 Adenocarcinoma ** Desmoplastic small round cell sarcoma, myxofibrosarcoma, pleomorphic sarcoma, and pleomorphic spindle cell sarcoma Overall response rates (ORR) at 26 months for R0 and R0 with Microscopic Positive Margins (R0-MPM) patients were 69% (95% CI, 19-40%) and 100% (95% CI, 100 – 100.0%), respectively. ORR was defined as no recurrence from the time of CHCP treatment to LRR in R0 resected patients. ORR was evaluated by postoperative T2 weighted MRI, PET or CT scans. Overall Survival (OS) for R0 (n=7), R0-MPM (n=5), R1 (n=6), and R2 (n=2) patients at 28 months were 86%, 40%, 67%, and 0%, respectively. The cumulative OS rate was 24% at 31 months (n=20, 95% CI, 5.3 – 100.0). OS was defined as the duration from the intraoperative CHCP treatment to death. CHCP treatment did not affect intraoperative physiological vital signs (blood pressure, pulse, O 2 saturation, end tidal CO 2 , and temperature, p > 0.05). No systemic toxicities or device-related adverse events were observed. Overall, CHCP treatment combined with surgery is safe, selective towards microscopic tumor cells at the margin, and demonstrates exceptionally low LRR in R0 and R0-MPM patients. Time (Months) Number at Risk Deaths Survival Rate Standard Error Lower 95% CI Upper 95% CI 0 20 0 100% 0.00 1.00 1.00 5 18 2 90% 0.07 0.78 1.00 10 16 3 75% 0.10 0.58 0.97 15 15 0 75% 0.10 0.58 0.97 20 15 1 70% 0.10 0.53 0.93 25 8 0 70% 0.10 0.53 0.93 30 3 2 48% 0.15 0.26 0.88 31 2 1 24% 0.19 0.05 1.00 OS analysis for CAP-treated patients (n=20). P=0.0058. Jerome Canady, MD., FACS., Surgical Oncologist, and CEO stated, “One inherent problem of excising any solid tumor tissue is ensuring complete surgical removal of the tumor and the microscopic tumor cells at the margins, which reduces the chance of local regional recurrence. To date, there are no treatments on the market that ensure the complete eradication of microscopic tumor cells at the surgical margin without damaging the surrounding healthy tissue. CHCP treatment with surgery shows immense promise in controlling local recurrence and improving survival in patients with advanced solid tumors. The treatment selectively kills microscopic tumor cells at the surgical margin. CHCP treatment is non-invasive, administered for 5 - 7 minutes intraoperatively, and has no side effects. It seamlessly integrates into existing treatment protocols without disruption." Professor of Surgery Giacomo Basadonna MD., Ph.D., FACS Department of Surgery University of Massachusetts School of Medicine Worcester and co-author of the study stated, "The results of this clinical investigation are truly remarkable and offer renewed hope to cancer patients with advanced disease. The data from the trial combined with the amount of mechanistic information collected over many years, clearly show that Canady Helios Cold Plasma treatment causes cancer cells to die within a brief period leaving normal tissue untouched. The current trial shows that treating the surrounding tissue following tumorectomy prevents local recurrence and increases overall survival. Although this trial was conducted in patients with severe disease for regulatory reasons, the results open the door to treating the tumor bed and the adjacent tissue following removal of primary malignancies and truly guarantee cancer-free surgical margins." These groundbreaking results highlight the safety, selectivity, and significant reduction of local regional recurrence achieved through the combination of CHCP treatment and surgery. USMI's Canady Helios Cold Plasma system opens a new and promising avenue for addressing the challenges of eradicating microscopic residual cancer cells following surgical tumor resection without damaging surrounding healthy tissue. JCRI-ABTS and USMI thank the participating patients and their families, prior compassionate use patients, surgical teams performing these advanced surgical procedures, and allowance by SMC and RUMC. USMI’s FDA Phase 2 Multi-Center Clinical Trial is expected to take place in Q/4 2023. The accompanying report for this Phase 1 Clinical Trial has been submitted to a peer review journal. The Abstract can be viewed on the ASCO website at https://meetings.asco.org/abstracts-presentations/225003 Reference data 1 JCRI Discovers the Mechanism using Canady Helios™ Cold Plasma to Induce Cell Death in Breast Cancer For more information about the CHCP clinical trial and USMI's innovative medical technologies, please visit ClinicalTrials.gov identifier: NCT04267575. About US Medical Innovations US Medical Innovations, LLC (USMI), based out of Takoma Park, MD, is a privately held FDA registered life science and biomedical device company. USMI is dedicated to expanding the boundaries of plasma medicine by pioneering new technologies for the development of state-of-the-art medical devices that advance patient outcomes and improve human lives.