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.

On May 24, 2022 Indica Labs, the leading provider of computational pathology software and services, reported a CE-IVD Mark for HALO Prostate AI, a deep learning-based screening tool designed to assist pathologists in identifying and grading prostate cancer in core needle biopsies (Press release, Indica Labs, MAY 24, 2022, View Source [SID1234614970]).

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Prostate cancer is the most common cancer diagnosed in men. With over 1.4 million cases reported worldwide in 2020, the incidence rates continue to rise with wider availability of screening tests, such as PSA. Each prostate case consists of multiple biopsy core whole slide images, which must be assessed by a pathologist for the presence of tumor and, if present, a Gleason score is reported. This represents a large workload for pathologists who screen multiple cases daily. HALO Prostate AI is designed to work alongside the pathologist to improve efficiency and to add a layer of quality control to ensure diagnostic accuracy.

Developed in close collaboration with Dr. Yuri Tolkach and colleagues from the University of Cologne, HALO Prostate AI was trained using over 870,000 training patches obtained from the annotation of digital scans representing the full spectrum of prostate cancer subtypes and Gleason grades, as well as benign tissue. The algorithm achieved high sensitivity (95- 100%), specificity (88-98%) and negative predictive value (98- 100%) in validation studies performed on 4,973 core needle biopsies from three independent cohorts sourced from hospitals in Austria and Germany. Highlighting the unique benefit of HALO Prostate AI screening on diagnostic accuracy and patient care, the algorithm correctly detected tumor in 26 cores within the validation study that were originally reported as tumor negative.

In a separate study, Gleason scores obtained from HALO Prostate AI were compared against scores assigned by pathologists located in ten globally distributed hospitals. Nine pathologists who participated in the study were board-certified in genitourinary pathology. High concordance was achieved for two separate cohorts with representative average quadratic Kappa scores of 0.8 and 0.7.

"I am very excited about the digital future of pathology," commented Dr. Tolkach. "With tools such as HALO Prostate AI, our work can be substantially optimized while controlling for high-quality, reliable, and objective diagnostics. HALO Prostate AI showed very high accuracy in the large multi-institutional study for tumor detection and Gleason Grading in prostate biopsies. It’s really enjoyable to work back-to-back with such a powerful AI assistant".

Dr. Peter Caie, Principal Scientist of AI Collaboration at Indica Labs, added, "This has been a hugely positive collaboration with Dr. Tolkach and contributing pathologists from around the world. We set out to build a clinical-grade algorithm that could improve turn-around time and diagnostic accuracy for prostate cancer patients, and I believe that is exactly what we have achieved. We are thrilled to see the first of many AI algorithms from Indica Labs attain CE-IVD marking and to begin to be used in clinical settings to help alleviate the pressure of ever-increasing workloads."

HALO Prostate AI is deployed through Indica Labs’ CE-IVD marked HALO AP platform to provide a fully validated and automated end-to-end workflow. HALO AP can operate as a fully functional, standalone case management system or can integrate with existing LIS solutions to allow outputs from HALO Prostate AI or other AI diagnostics to be accessible directly from the LIS. Designed to be scanner agnostic, HALO Prostate AI was trained using digital scans obtained from multiple scanning platforms and was clinically validated against the Hamamatsu NanoZoomer S360 and Leica GT450 platforms.

On May 24, 2022 Incyte (Nasdaq:INCY) reported that it will present at the 43rd Annual Goldman Sachs Global Healthcare Conference on Tuesday, June 14, 2022 at 8:00 a.m. (PDT) /11 a.m. (EDT) in Rancho Palos Verdes (Press release, Incyte, MAY 24, 2022, View Source [SID1234614991]).

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The presentation will be webcast live and can be accessed at Investor.Incyte.com and will be available for replay for 30 days.

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.

On May 24, 2022 Chinook Therapeutics, Inc. (Nasdaq: KDNY) reported the pricing of its underwritten public offering of 6,428,572 shares of its common stock at a price to the public of $14.00 per share (Press release, Aduro Biotech, MAY 24, 2022, View Source [SID1234615025]). In addition, and in lieu of common stock, Chinook is offering to certain investors pre-funded warrants to purchase up to an aggregate of 1,071,428 shares of common stock at a purchase price of $13.9999 per pre-funded warrant, which represents the per share public offering price for the common stock less the $0.0001 per share exercise price for each such pre-funded warrant. The gross proceeds to Chinook from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Chinook, are expected to be $105 million. Chinook has granted the underwriters a 30-day option to purchase up to an additional 1,125,000 shares of common stock in connection with the public offering. The offering is expected to close on or about May 27, 2022, subject to the satisfaction of customary closing conditions. All of the securities are being offered by Chinook.

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SVB Securities, Cantor and William Blair are acting as joint book-running managers for the offering. Wedbush PacGrow is acting as lead manager for the offering.

Chinook intends to use the net proceeds from this offering to continue its phase 3 ALIGN and phase 2 AFFINITY trials of atrasentan, fund a phase 3 clinical trial of BION-1301, continue development of CHK-336 and prepare for the potential commercial launch of atrasentan. The remainder of the net proceeds, if any, will be used for general corporate purposes.

The public offering is being made pursuant to a shelf registration statement (File No. 333-265168) on Form S-3ASR that was filed by Chinook with the Securities and Exchange Commission ("SEC") on May 24, 2022, which became automatically effective upon filing with the SEC. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering was filed with the SEC and is available on the SEC’s website at www.sec.gov. A copy of the final prospectus supplement relating to the offering, when available, may be obtained from: SVB Securities LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, 4th Floor, New York, NY 10022, by email at [email protected]; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, by telephone at (800) 621-0687, or by email at [email protected].

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