PreludeDx™ to Present DCIS Study Results Assessing Benefit of Adjuvant Endocrine Therapy Using DCISionRT® During Oral Presentation at ASCO 2022 Annual Meeting

On May 24, 2022 Prelude Corporation (PreludeDx), a leader in molecular diagnostics and precision medicine for early-stage breast cancer, reported that its study in 926 DCIS patients demonstrating the clinical utility of DCISionRT was selected for an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Prelude Therapeutics, MAY 24, 2022, View Source [SID1234615008]). The results evaluating the association of DCISionRT, a predictive DCIS Biosignature to assess the impact of Endocrine Therapy (ET) on 10-year ipsilateral breast recurrence (IBR) risk after breast conserving surgery alone or with radiation therapy (RT), will be presented on June 7, 2022 at McCormick Place, Chicago, IL.

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"We continue to expand the clinical evidence and utility of DCISionRT and are excited to have been selected for oral presentation at the prestigious ASCO (Free ASCO Whitepaper) Annual Meeting," said Dan Forche, President and CEO of PreludeDx. "These results amplify the extensive body of clinical evidence empowering physicians and patients to make personalized early-stage breast cancer treatment decisions and enhance patient outcomes."

Oral Abstract Presentation
Title: Assessing the benefit of adjuvant endocrine therapy in patients following breast conserving surgery with or without radiation stratified by a 7-gene predictive DCIS biosignature
Presenter: Pat Whitworth, MD, FACS, FSSO, Nashville Breast Center, and Associate Professor, University of Tennessee
Location: Hall D1
Date: Tuesday, June 7, 9:57 am CDT

About DCISionRT for Breast DCIS
DCISionRT is the only risk assessment test for patients with ductal carcinoma in situ (DCIS) that predicts radiation therapy benefit. Patients with DCIS have cancerous cells lining the milk ducts of the breast, but they have not spread into surrounding breast tissue. In the US, over 60,000 women are newly diagnosed with DCIS each year. DCISionRT, developed by PreludeDx on technology licensed from the University of California San Francisco, and built on research that began with funding from the National Cancer Institute, enables physicians to better understand the biology of DCIS. DCISionRT combines the latest innovations in molecular biology with risk-based assessment scores to assess a woman’s individual tumor biology along with other pathologic risk factors and provide a personalized recurrence risk. The test provides a Decision Score that identifies a woman’s risk as low or elevated. Unlike other risk assessment tools, the DCISionRT test combines protein expression from seven biomarkers and four clinicopathologic factors, using a non-linear algorithm to account for multiple interactions between individual factors in order to better interpret complex biological information. DCISionRT’s intelligent reporting provides a woman’s recurrence risk after breast conserving surgery alone and with the addition of radiation therapy. In turn, this new information may help patients and their physicians to make more informed treatment decisions.

CNS Pharmaceuticals Announces Presentation at the H.C. Wainwright Global Investment Conference

On May 24, 2022 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, reported that John Climaco, Chief Executive Officer of CNS Pharmaceuticals, will be participating at the H.C. Wainwright Global Investment Conference being held May 23-26, 2022 in Miami, FL and virtually (Press release, CNS Pharmaceuticals, MAY 24, 2022, https://www.prnewswire.com/news-releases/cns-pharmaceuticals-announces-presentation-at-the-hc-wainwright-global-investment-conference-301553649.html [SID1234615007]).

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A video webcast of Mr. Climaco’s presentation is now accessible for viewing on-demand for those registered for the event and will be available on the Events page in the Investors section of the Company’s website (www.cnspharma.com). The webcast replay will be archived for 90 days following the event.

In addition to the presentation, management will be available to participate in virtual one-on-one meetings with qualified members of the investor community who are registered to attend the conference. For more information, please visit the conference website.

Myeloid Therapeutics to Participate at Investor Conferences in June 2022

On May 24, 2022 Myeloid Therapeutics, Inc. ("Myeloid"), a clinical stage mRNA-immunotherapy company developing novel therapies for cancer and autoimmune diseases, reported that it will participate in the following investor conferences during June 2022 (Press release, Myeloid Therapeutics, MAY 24, 2022, View Source [SID1234615006]):

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Wells Fargo Private Biotech Symposium, taking place virtually on June 1, 2022
Jefferies Healthcare Conference, taking place in New York, NY, June 8-10th, 2022. Daniel Getts, Ph.D., CEO of Myeloid, will present a company overview on Friday, June 10th, at 12:15 pm ET.

Neurocrine Biosciences Announces Repurchase of Convertible Notes

On May 24, 2022 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) (the "Company" or "Neurocrine Biosciences") reported that it has entered into separate, privately negotiated transactions (the "Agreements") with certain holders of its existing 2.25% Convertible Senior Notes due 2024 (the "2024 Notes") to repurchase approximately $179.4 million aggregate principal amount of the 2024 Notes for an aggregate repurchase price of an amount of cash estimated to be the sum of (i) approximately $224.0 million, (ii) an amount based in part on the trading price of the Company’s common stock and (iii) accrued and unpaid interest (Press release, Neurocrine Biosciences, MAY 24, 2022, View Source [SID1234615004]). The 2024 Notes repurchases are expected to close over a period ending on June 14, 2022, subject to customary closing conditions. Such repurchases of the 2024 Notes could affect the market price of the Company’s common stock.

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Following these repurchases, approximately $201.8 million aggregate principal of the Company’s 2024 Notes will remain outstanding, from an initial principal balance of $517.5 million. "Given our balance sheet flexibility, we have now reduced our convertible debt levels by approximately 60% over the past two years in an effort to minimize dilution for our shareholders," said Matt Abernethy, Chief Financial Officer of Neurocrine Biosciences. "Our capital allocation priorities remain focused on growing INGREZZA and advancing our mid-to-late-stage clinical programs."

This press release does not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any offer or sale of these securities in any state or jurisdiction in which the offer, solicitation, or sale would be unlawful prior to the registration or qualification thereof under the securities laws of any such state or jurisdiction.

Iterative Scopes Unveils Registration Trial Data Showing Improvement in Colonoscopy Procedure Efficacy with Computer-Aided Device SKOUT™

On May 24, 2022 Iterative Scopes, a pioneer in precision medicine technologies for gastroenterology, reported that the company’s automated polyp detection algorithm for colorectal cancer (CRC) screening, SKOUT, demonstrated statistical superiority of overall adenoma detection in a randomized, controlled prospective clinical trial, compared to routine colonoscopy (Press release, Iterative Scopes, MAY 24, 2022, View Source [SID1234615003]). The 27% relative improvement in adenomas per colonoscopy (APC) detection in a relatively average-risk patient population reflects one additional adenoma detected among every 4.5 patients screened and occurred without decreasing safety or workflow efficiency, important considerations for gastroenterologists performing the procedures. The results from the registration trial were also accepted for publication in Gastroenterology.

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SKOUT is a computer-aided device (CADe) that uses artificial intelligence and advanced computer vision technology to recognize suspicious tissue and provide real-time feedback to gastroenterologists. The goal is to detect suspicious lesions early, which has been shown to decrease incidence of CRC.1 CRC is the second leading cause of cancer deaths in the United States and Europe.2,3

Aasma Shaukat, MD, MPH, the Robert M. and Mary H. Glickman Professor of Medicine and Gastroenterology at NYU Grossman School of Medicine, presented the findings in an oral presentation entitled "Increased Adenoma Detection with the use of a novel computer aided detection device, SKOUT: Results of a multicenter randomized clinical trial in the US" during a "Late-Breaking Clinical Science Abstract Plenary" session (No. 5095) on Tuesday, May 24 at 8:15 AM PDT. Her comments were the first public disclosure of data from the clinical trial, which Iterative Scopes submitted to the FDA in a 510(k) filing for review in November 2021. The 510(k) clearance for SKOUT is pending, it is not currently for sale in the United States.

"The results from this study indicate that CADe polyp-detection devices can enhance the quality of colonoscopy and are an important addition in the endoscopy suite," said Dr. Shaukat. "Improving detection of adenomas per colonoscopy without increasing the rate of removal of healthy tissue has the potential of making our colonoscopy practice even more effective in the prevention of colorectal neoplasia."

Colonoscopies are routinely performed to screen for CRC with the goal of detecting precancerous lesions, known as adenomas.1 Studies show that colonoscopies are highly operator dependent, and endoscopists miss up to 26% of adenomas.4

In the SKOUT registration study, 1359 randomized subjects were included in the primary analysis in two separate cohorts. One cohort underwent a colonoscopy procedure with the implementation of the SKOUT AI software, and the other group underwent a colonoscopy procedure without implementation of the SKOUT AI software. Twenty-two board-certified, experienced gastroenterologists from five academic medical and community centers in the United States participated in the trial.

Both primary study endpoints were met. Adenomas per colonoscopy increased significantly with the use of SKOUT compared to the control, and true histology rate (THR) did not significantly change between cohorts. APC is a quality metric of colonoscopy procedure efficacy and is defined as the number of detected adenomas in a procedure divided by the total number of screening colonoscopies.4 A recently published analysis of state cancer registries found that incidence of post-colonoscopy CRC within three years of baseline examination decreased among endoscopists with higher APC rates.5

THR is a measure of resection of non-neoplastic lesions. A decrease in THR may indicate a rise in the resection of histologically unimportant (healthy) tissue. In this study THR did not change significantly with the use of SKOUT compared to the control. These results were consistent in both the screening and surveillance populations.

The study resulted in additional findings demonstrating improved detection of clinically important lesions. The study met secondary endpoints showing that the use of SKOUT did not affect procedure withdrawal time nor total procedure time. This indicates that this technology may be able to be integrated smoothly into routine clinical practice. Full study results have been accepted by Gastroenterology and will be released in the near term.

Kahi CJ, Imperiale TF, Juliar BE, et al. Effect of screening colonoscopy on colorectal cancer incidence and mortality. Clin Gastroenterol Hepatol 2009;7:770-775.
Dyba T, Randi G, Bray F, et al. The European cancer burden in 2020: Incidence and mortality estimates for 40 countries and 25 major cancers. European Journal of Cancer 2021; 157: 308-347.
Rebeca S, Kimberly M, Ann Godin S, Colorectal Cancer Statistic, 2020. CA Cancer J Clin 2020; 70:145-164.
Zhao S, Wang S, Pan P, et al. Magnitude, risk factors, and factors associated with adenoma miss rate of tandem colonoscopy: a systematic review and meta-analysis. Gastroenterology 2019;156:1661-1674.e11.
Anderson J, Hisey W, Robinson C, et al. Mean adenomas per colonoscopy is inversely associated with post colonoscopy colorectal cancers: data from the New Hampshire Colonoscopy Registry validating this quality measure. Paper presented at: American College of Gastroenterology 2021 Annual Scientific Meeting; October 22-27, 2021; Las Vegas, Nevada.