On September 8, 2021 GT Biopharma, Inc. (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary natural killer (NK) cell engager, TriKE protein biologic technology platform, reported that Anthony Cataldo, Chairman & CEO, Dr. Greg Berk, President of R&D and Chief Medical Officer, and Dr. Jeff Miller, Consulting Chief Scientific Officer will be presenting and hosting one-on-one meetings at the upcoming H.C. Wainwright 23rd Annual Global Healthcare Conference and the Baird Global Healthcare Conference (Press release, GT Biopharma, SEP 8, 2021, View Source [SID1234587390]).

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Details for the presentations are as follows:

H.C. Wainwright 23rd Annual Global Healthcare Conference

Date: September 13, 2021
Pre-recorded Corporate Presentation Release Time: 7:00 A.M. ET
Webcast Participation: View Source

Additionally, the management team will participate in the following live panel presentation: "Novel Therapeutic Approaches to NK Therapy in Cancer" at 1:00P.M. ET

Baird Global Healthcare Conference

Date: September 15, 2021
Time: 8:30 A.M. ET
Registration: By invitation only

If you are interested in participating in either of the conferences or to schedule a one-on-one meeting with the management team, please contact your respective representative with each conference organizer.

On September 8, 2021 Cernostics, pioneer of the worlds’ first precision medicine test to predict future development risk of esophageal cancer from Barrett’s esophagus (BE), TissueCypher Barrett’s Esophagus Assay, reported that it has become a participating ("in- network") provider for Geisinger Health Plan (GHP)’s more than 550,000 plan members in Central, North Central and East Central Pennsylvania (Press release, Cernostics, SEP 8, 2021, View Source;utm_medium=rss&utm_campaign=cernostics-contracts-with-geisinger-health-plan-to-become-an-in-network-provider-for-tissuecypher-barretts-esophagus-assay [SID1234587389]). The TissueCypher Barrett’s Esophagus Assay has been a covered service for GHP members since a January 2021 decision determined that it was "medically necessary" for the evaluation of biopsies from certain BE patients, becoming the first commercial health care plan to have a coverage policy for TissueCypher.

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This decision by GHP comes in response to multiple recent peer-reviewed publications that independently validated the clinical validity and clinical utility of the TissueCypher Barrett’s Esophagus Assay.

Objectively and accurately predicting progression from BE to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC) is critical as the incidence of esophageal cancer is growing in the US at one of the fastest rates of all cancers. Once diagnosed, EAC is highly lethal, so early detection and advanced warning in patients with BE by TissueCypher provides valuable clinical decision support to physicians managing these patients.

"We’ve collaborated with Cernostics in the development of the clinical evidence demonstrating the value of TissueCypher for risk-stratification of patients with BE. TissueCypher uses biomarker information not available by any other technology and has allowed us to determine optimal treatment and follow-up strategies in an informed and intelligent way. Importantly, the test can be run on previously obtained biopsies. It’s exciting to see that our patients and gastroenterologists now have access to this important technology as a covered benefit and in-network lab service," said Dr. David Diehl, Director of Interventional Endoscopy at Geisinger Medical Center.

Mike Hoerres, Chief Executive Officer of Cernostics, added, "We are proud to work with Geisinger, one of the leading integrated healthcare delivery systems in the US, to bring TissueCypher testing to our neighbors throughout Pennsylvania. We see this as a great way to support the legacy and vision of Abigail Geisinger, delivering state-of-the-art medicine to the communities we serve right here in Pennsylvania."

On September 8, 2021 Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN) ("Diffusion" or the "Company"), an innovative biopharmaceutical company developing novel therapies that enhance the body’s ability to deliver oxygen to areas where it is needed most, reported that Robert Cobuzzi, Jr., Ph.D., Chief Executive Officer, will present at the H.C. Wainwright 23rd Annual Global Investment Conference taking place September 13-15, 2021 (Press release, Diffusion Pharmaceuticals, SEP 8, 2021, https://www.diffusionpharma.com/diffusion-pharmaceuticals-to-present-at-the-23rd-annual-h-c-wainwright-global-investment-conference/ [SID1234587388]). The prerecorded presentation will be available starting at 7 a.m. ET on September 13, 2021 and will be accessible via the conference’s virtual platform by registered conference attendees. The presentation will be archived and available for viewing for 90 days, following the conference.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Dr. Cobuzzi will provide an overview of Diffusion’s business highlights and recent corporate and clinical achievements, as well as anticipated milestones in the clinical programs for trans sodium crocetinate (TSC), Diffusion’s lead product candidate. Diffusion has completed the first of three Oxygenation Trials, which are intended to guide the selection of indications and doses to be pursued for future development of TSC. Diffusion plans to select the initial indication by year-end 2021, and initiate a Phase 2 trial in that indication in the first half of 2022.

Additionally, Dr. Cobuzzi and members of the Diffusion management team will be participating in virtual one-on-one meetings with registered investors and pharmaceutical company executives.

Details of the presentation are as follows:

Event: H.C. Wainwright 23rd Annual Global Investment Conference
Date: September 13-15, 2021
Time: Presentation available starting at 7 a.m. ET on September 13, 2021
Registration: View Source
Following the conclusion of the event, a recording of Dr. Cobuzzi’s presentation will be available under "Presentations" in the Investors section of the Company’s website at View Source

On September 8, 2021 HiberCell, a clinical stage biotechnology company developing therapeutics to treat cancer relapse and metastasis, reported that the U.S. Food and Drug Administration (FDA) has granted the company Fast Track designation for HC-5404-FU, an orally administered PERK inhibitor (PERKi) for patients with solid tumors (Press release, HiberCell, SEP 8, 2021, View Source [SID1234587387]). As reported in June 2021, the company initiated a first-in-human, Phase 1a clinical trial for HC-5404-FU in select solid tumors filed their Investigational New Drug (IND) application, and received FDA authorization to begin clinical studies in late 2020.

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A Fast Track designation from the FDA provides several benefits for HiberCell’s HC-5404-FU PERKi therapeutic, including more frequent meetings with the FDA to discuss the drug development plan, additional written communications from the FDA regarding the design of the proposed clinical trials, the use of biomarkers, and Rolling Review, which means HiberCell can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until all sections of the NDA are completed. Additionally, with this designation, HC-5404-FU will automatically be considered for Accelerated Approval and Priority Review. Accelerated Approval is based on a surrogate endpoint reasonably likely to predict clinical benefit; Priority Review shortens the FDA review process from ten months to six.

"The Fast Track designation is an important step as HiberCell focuses on advancing this first-in-class clinical asset," said Alan Rigby, PhD, chief executive officer at HiberCell. "Importantly, this designation will allow us to work closely with the FDA to quickly move HC-5404-FU through our ongoing clinical trial, HC-404-FCP-2011. The trial is a first in-human, Phase 1a, multi-center, open-label study to establish the maximum tolerated dose (MTD) and evaluate the safety and tolerability following oral dosing of HC-5404-FU in a dose-escalating fashion. Up to 24 qualified subjects at five US sites, who have specific solid tumors, including renal cell carcinoma (RCC), gastric cancer (GC), and other solid tumors are planned for enrollment in this study. This Phase 1a study will be expanded into a Phase 1b/2a through a protocol amendment with the dose and tumor type(s) identified in Phase 1a as the most appropriate for further clinical development."

On September 8, 2021 GlycoMimetics, Inc. (Nasdaq: GLYC) reported that Chief Executive Officer Harout Semerjian will present at the upcoming H.C. Wainwright & Co 23rd Annual Global Investment Virtual Conference taking place September 13-15, 2021 (Press release, GlycoMimetics, SEP 8, 2021, https://ir.glycomimetics.com/news-releases/news-release-details/glycomimetics-present-upcoming-hc-wainwright-co-annual-global-0 [SID1234587386]). The presentation will be available on the company’s website at the "Investors" tab for 30 days, beginning Monday, September 13 at 7:00 a.m. EDT.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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To access the live webcast and subsequent archived recordings for the presentation, please visit the GlycoMimetics website at View Source