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Nykode Therapeutics – 3Q 2022 Financial Results – presentation

On November 23, 2022 Nykode Therapeutics Presented the Corporate Presentation (Press release, Nykode Therapeutics, NOV 23, 2022, View Source [SID1234624411]).

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BeyondSpring Receives Nasdaq Notice Regarding Minimum Bid Price Requirements

On November 23, 2022 BeyondSpring Inc. (the "Company" or "BeyondSpring") (Nasdaq: BYSI), a clinical stage global biopharmaceutical company focused on developing innovative cancer therapies, reported that on November 18, 2022, it received a written notification from The Nasdaq Stock Market LLC ("Nasdaq") that the Company is not in compliance with the requirement to maintain a minimum closing bid price of $1.00 per share, as set forth in Nasdaq Listing Rule 5550(a)(2), because the closing bid price of the Company’s ordinary shares (the "Ordinary Shares") was below $1.00 per share for 30 consecutive business days (Press release, BeyondSpring Pharmaceuticals, NOV 23, 2022, View Source [SID1234624409]). The notification letter does not result in the immediate delisting of the Company’s Ordinary Shares and has no current immediate effect on the listing or trading of the Company’s Ordinary Shares on Nasdaq.

Pursuant to the Nasdaq Listing Rule 5810(c)(3)(A), the Company is provided with a compliance period of 180 calendar days from the date of the notification letter, or until May 17, 2023, to regain compliance with the minimum bid price requirement. During this period, the Company’s Ordinary Shares will continue to trade on Nasdaq. If at any time before May 17, 2023, the bid price of the Company’s Ordinary Shares closes at or above $1.00 per share for a minimum of ten consecutive trading days, Nasdaq will provide written confirmation of compliance and this matter will be closed. In the event the Company does not regain compliance by May 17, 2023, subject to the determination by the staff of Nasdaq, the Company may be eligible for an additional 180-day compliance period.

The notification letter does not affect the Company’s business operations, and the Company is considering all available options to regain compliance with the listing rules within the prescribed grace period.

Gracell Biotechnologies to Participate in Two Upcoming Investor Conferences

On November 23, 2022 Gracell Biotechnologies Inc. (NASDAQ: GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to discovering and developing highly efficacious and affordable cell therapies for the treatment of cancer, reported that the management team will participate in and attend one-on-one meetings at two upcoming investor conferences (Press release, Gracell Biotechnologies, NOV 23, 2022, View Source [SID1234624407]).

Piper Sandler 34th Annual Healthcare Conference
Presentation: November 30th at 4:00 pm ET
One-on-one meetings: Wednesday, November 30, 2022
Location: New York, NY

JMP Securities Hematology & Oncology Summit (virtual)
Presentation: December 7th at 10:00 am ET
One-on-one meetings: December 6 – 7, 2022

Webcast of the fireside chat will be available on the News and Events section of Gracell’s investor website. A replay of the webcast will be available for 30 days following the event.

AnchorDx Enrolls the First Patient For Its UriFind® Bladder Cancer Assay Clinical Trial in the U.S.

On November 23, 2022 AnchorDx, a world-leading developer of cancer early detection solutions, reported the first patient enrollment for the UriFind bladder cancer assay clinical trial in the U.S., an over 1,000-patient multi-center, prospective testing of the assay in the targeted patients (Press release, AnchorDx, NOV 23, 2022, View Source [SID1234624406]). This prospective, registrational study is aimed to evaluate the performance of the non-invasive, quantitative real-time PCR (qPCR) assay designed to detect two DNA methylation biomarkers in urine specimens from patients suspected of having bladder cancer. In July 2021, the assay was granted a Breakthrough Device Designation (BTD) by the U.S. Food and Drug Administration (FDA). Results of this clinical trial are aimed towards meeting the requirements for an application for a Premarketing Approval (PMA) to the FDA in the U.S. The trial is expected to include about 10 sites of Urology clinics and 3 CAP/CLIA laboratories.

Bladder cancer is a common type of cancer with a high recurrence rate. It has an estimated 84,000 new cases, and 17,300 deaths in the U.S. in 2021 (American Cancer Society). The majority (>90%) of bladder cancer cases are urothelial carcinomas. Cystoscopy, followed by biopsy of suspicious lesions, remains the gold standard for diagnosis of both new and recurrent bladder cancer. However, the approach is highly invasive and costly, due to which bladder cancer is being called the most expensive single cancer. In addition, urine cytology and other methods have poor performance as compared with cystoscopy. UriFind is a urine-based, non-invasive molecular test for accurate detection of bladder cancer. The performance of the UriFind test has shown to provide improved sensitivity and specificity over cytology and other assays. It offers advantages in the detection of early, micro, residual and recurrent bladder cancer, and provides a sound basis for the clinical diagnosis of bladder cancer.

"The UriFind bladder cancer assay clinical study is the first clinical trial initiated by AnchorDx in the U.S. Building upon our proprietary science and technology in measuring DNA methylation, we have developed this high performing test for detection of bladder cancer. We are excited to evaluate its ability to inform patient care" said Marina Bibikova, Chief Scientific Officer of AnchorDx.

"AnchorDx is committed to transform early detection and diagnosis of cancer as we continuously bring our tests into clinical practice through clinical validation" said Jian-Bing Fan, Founder and Chief Executive Officer. "We are collaborating with leading urologists world-wide to gain important clinical evidence on the use of our UriFind test. This clinical trial represents an important step towards commercialization of the test in the U.S."

At present, UriFind has completed the registered clinical trial in China and was granted a priority review in August 2022 by the China National Medical Products Administration (NMPA) because of its clinical superiority. It has also gained EU CE certification. As an innovative biotechnology enterprise in China with a global perspective, AnchorDx is making every effort to accelerate the global market authorization of UriFind, with a goal to serve more people in need.

Additional information about the UriFind assay clinical trial is available on clinicaltrials.gov.

GNS Announces Abstract and Oral Poster Presentation at CTAD & ASH, 2022 Annual Conferences

On November 23, 2022 GNS, the leader in the application of Causal AI and simulation and "Digital Twins" to discover new drugs, reported two abstracts and two oral poster presentations highlighting insight from the Gemini Digital Twin models in Alzheimer’s Disease and Multiple Myeloma will be included at the Clinical Trials on Alzheimer’s Disease conference (CTAD) in San Francisco and the American Society of Hematology (ASH) (Free ASH Whitepaper) in New Orleans (Press release, GNS Healthcare, NOV 23, 2022, View Source;ash-2022-annual-conferences-301686187.html [SID1234624405]).

Oral Poster Presentations:
Two oral poster presentations highlighting insight from the Gemini Digital Twin models in AD and MM will be included

CTAD – Abstract Title: Causal in silico Patient Models can inform Alzheimer’s Disease Patient Identification and Endpoint Selection for Early-Stage Clinical Trials

Authors: So-Youn Shin, Shokeen Deepanshi, Apoorva Bharthur, Todd Oakland, and Jeanne Latourelle

Location: Poster #158, Theme: Cognitive Assessment and Clinical Trials

Date: Friday, December 2nd, 2022, 8:00 AM-5:00 PM

ASH – Abstract Title: Causal AI in silico Patient Model Identifies Minichromosome Maintenance (MCM) Family Genes as Novel Predictors for Overall Survival in Multiple Myeloma

Authors: Daniel Vagie, Derek Walkama, Laurel Mayhew, Todd Oakland, and Bruce Church

Location: Session 803, Emerging Tools, Techniques and Artificial Intelligence in Hematology: Poster III

Date: Monday, December 12, 2022, 6:00 PM-8:00 PM

In accordance with CTAD and ASH (Free ASH Whitepaper) policies, abstracts and posters submitted are embargoed from the time of submission. Full text of both abstracts and posters will be made available on GNS website following their respective presentations at the conferences.