Lipocine Announces Pro Rata Distribution of Series B Preferred Stock to its Holders of Common Stock

On March 10, 2023 Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, reported that its Board of Directors declared a dividend of one one-thousandth of a share of newly designated Series B Preferred Stock, par value $0.0001 per share, for each outstanding share of the Company’s common stock held of record as of 5:00 p.m. Eastern Time on March 24, 2023 (Press release, Lipocine, MAR 10, 2023, View Source [SID1234628517]). The shares of Series B Preferred Stock will be distributed to such recipients at 5:00 p.m. Eastern Time on March 24, 2023. The outstanding shares of Series B Preferred Stock will vote together with the outstanding shares of the Company’s common stock, as a single class, exclusively with respect to a reverse stock split, as well as any proposal to adjourn any meeting of stockholders called for the purpose of voting on the reverse stock split, and will not be entitled to vote on any other matter, except to the extent required under the Delaware General Corporation Law. Subject to certain limitations, each outstanding share of Series B Preferred Stock will have 1,000,000 votes per share (or 1,000 votes per one one-thousandth of a share of Series B Preferred Stock).

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All shares of Series B Preferred Stock that are not present in person or by proxy at the meeting of stockholders held to vote on the reverse stock split as of immediately prior to the opening of the polls at such meeting will automatically be redeemed by the Company. Any outstanding shares of Series B Preferred Stock that have not been so redeemed will be redeemed if such redemption is ordered by the Company’s Board of Directors or automatically upon the approval by the Company’s stockholders of an amendment to the Company’s certificate of incorporation effecting the reverse stock split at such meeting. After the redemption of the Series B Preferred Stock, the Company’s capitalization structure will be as it was prior to the dividend of the Series B Preferred Stock, with the same number of common shares outstanding as were outstanding prior to the March 24, 2023 dividend of the Series B Preferred Stock, without giving effect to the issuance of common stock in connection with a stock option exercise or other sales of common stock by the Company.

The Series B Preferred Stock will be uncertificated, and no shares of Series B Preferred Stock will be transferable by any holder thereof except in connection with a transfer by such holder of any shares of the Company’s common stock held by such holder. In that case, a number of one one-thousandth of a share of Series B Preferred Stock equal to the number of shares of the Company’s common stock to be transferred by such holder would be transferred to the transferee of such shares of common stock.

Further details regarding the Series B Preferred Stock will be contained in a report on Form 8-K to be filed by the Company with the Securities and Exchange Commission.

Kintara Therapeutics Scheduled to Present at Two Conferences the Week of March 13, 2023

On March 10, 2023 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported its participation in two upcoming conferences (Press release, Kintara Therapeutics, MAR 10, 2023, View Source [SID1234628516]).

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35th Annual ROTH Conference, March 12-14, 2023 – Dana Point, CA
Mr. Robert E. Hoffman, President and CEO, will give a corporate update.
Presentation time – Monday, March 13, 2023, at 10:30 a.m. Pacific Time
4th Annual Glioblastoma Drug Development Summit, March 14-16, 2023 – Boston, MA
Dr. Dennis Brown, Chief Scientific Officer and Mr. Greg Johnson, Acting Head of Operations, will present a summary of the glioblastoma landscape and the unique attributes of Kintara’s VAL-083 program for glioblastoma.
Presentation time – Wednesday, March 15, 2023, at 4:00 p.m. Eastern Time

Guardant Health submits premarket approval application to the U.S. Food and Drug Administration for Shield™ blood test

On March 10, 2023 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that it has submitted to the U.S. Food and Drug Administration (FDA) the final module of its premarket approval (PMA) application for Shield, Guardant Health’s blood test to screen for colorectal cancer (CRC) (Press release, Guardant Health, MAR 10, 2023, View Source [SID1234628515]).

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The submission is comprised of data from the company’s positive ECLIPSE study, an over 20,000 patient registrational study evaluating the performance of its blood test for detecting colorectal cancer in average-risk adults. Preliminary results from the study showed that the Shield test achieved 83% sensitivity for the detection of colorectal cancer with specificity of 90%.

"Completing our FDA PMA application for Shield is a significant step forward toward our mission of saving millions of life-years through accessible blood-based cancer screening. We are looking forward to partnering with the agency on bringing this life-saving test to the market," said AmirAli Talasaz, co-CEO of Guardant Health. "Colorectal cancer is the second leading cause of cancer related death, yet one in three eligible adults are not up to date with screening.1 Patient access to blood-based screening can help overcome barriers to traditional screening modalities, especially in underserved populations."

The success of a CRC screening program depends on having tests with acceptable performance, but also on the willingness of the target population to complete the screening test.2 Since the launch of the lab developed version of the Shield test in May 2022, it has shown approximately 90% adherence in a real-world clinical setting, demonstrating the value of blood-based screening to increase adherence to recommended screening protocols.3 In fact, the effective sensitivity of the test, which measures the true impact of a screening test by evaluating adherence and test performance, shows that Shield has the potential to detect more CRCs than traditional modalities.3,4,5,6

About the ECLIPSE study

ECLIPSE is a prospective registrational study to evaluate the performance of Guardant Health’s blood test in detecting signs of CRC compared to a screening colonoscopy in average-risk adults between the ages of 45 and 84 from across the U.S. The ECLIPSE study included more than 200 clinical trial sites in rural and urban communities across 34 states. Study data includes 13% Black, 15% Hispanic and 7% Asian American populations. Enrollment among Black Americans was above average for a clinical trial, which is important given the disproportionate impact of CRC on the black community.7

About the Shield Test

The Shield test detects colorectal cancer signals in the bloodstream from DNA that is shed by tumors, called circulating tumor DNA (ctDNA). Specifically, the test identifies specific characteristics of the DNA that may indicate the presence of cancer.

The clinical performance of the Shield assay was validated using an analyzed set of over ten thousand patient samples in a screening study. The test demonstrated 83% sensitivity in detecting individuals with CRC. Specificity was 90% in both individuals without advanced neoplasia and in those who had a negative colonoscopy result. This test also demonstrated 13% sensitivity in detecting advanced adenomas.

Shield is commercially available for eligible individuals by prescription only through healthcare professionals. This LDT (Laboratory Developed Test) is intended to be complementary to, and not a replacement for, current recommended CRC screening methods. A negative result does not rule out the presence of cancer. Patients with an abnormal blood-based screening result should be referred for a diagnostic colonoscopic evaluation.

More information about the Shield test is available at bloodbasedscreening.com.

Galera Announces Presentation of Supplemental Analysis of Phase 3 ROMAN Trial at European Congress on Head and Neck Oncology

On March 10, 2023 Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, reported the presentation of a net treatment benefit analysis of Phase 3 ROMAN results at the 10th European Congress on Head and Neck Oncology (ECHNO), taking place March 8-11, 2023, in Lisbon, Portugal (Press release, Galera Therapeutics, MAR 10, 2023, View Source [SID1234628514]). The analysis further demonstrates the overall impact of avasopasem manganese (avasopasem) in reducing the burden of severe oral mucositis (SOM). Galera’s New Drug Application (NDA) in the U.S. for avasopasem is currently under U.S. Food and Drug Administration (FDA) priority review for radiotherapy (RT)-induced SOM in patients with head and neck cancer undergoing standard-of-care treatment.

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"We are pleased to present at ECHNO the results of the Phase 3 ROMAN trial, including a net treatment benefit analysis submitted as part of Galera’s NDA," said Mel Sorensen, M.D., President and Chief Executive Officer of Galera Therapeutics. "This analysis is particularly appropriate for SOM, where we believe that no single endpoint fully characterizes the potential impact of SOM on patient quality of life. We believe the results reinforce avasopasem’s first-in-class potential to reduce SOM, a common and debilitating effect of radiotherapy in patients with head and neck cancer. As we work with the FDA on the potential to bring avasopasem to U.S. patients, we also look forward to discussions with European regulatory authorities on a path for patients in Europe."

Presentation Details:

Title: Net treatment benefit of avasopasem manganese for severe oral mucositis from the ROMAN trial
Abstract Number: 93
Presenter: Carryn M. Anderson, M.D., University of Iowa Hospitals & Clinics
Session Title: QOL in H&N Cancer Treatment
Session Date and Time: Friday, March 10th, 2023 | 9:00 a.m. GMT
Session Location: Auditorium I, Lisbon Congress Centre

The presentation is available on Galera’s website at View Source

Results from two randomized, double-blind, placebo-controlled trials (Phase 3 ROMAN and Phase 2b GT-201) are the basis of the avasopasem NDA. The Company believes that the supplemental net treatment benefit analysis being presented at ECHNO further supports the avasopasem clinical benefit observed in those trials. It quantitatively demonstrates that the overall improvement in SOM is greater than that captured by any individual endpoint and that the improvement in each of the key SOM endpoints contributes to the benefit. The FDA accepted the filing and granted priority review to the NDA in February 2023, with a PDUFA target date of August 9, 2023. The FDA previously granted Breakthrough Therapy and Fast Track designations to avasopasem for the reduction of RT-induced SOM.

Head and neck cancers are a global problem, as is SOM caused by the standard-of-care RT. The Company intends for avasopasem to help patients beyond the U.S. and plans to meet with the European Medicines Agency (EMA) in 2023 to discuss the potential European registration pathway for avasopasem.

BIO-TECHNE TO PRESENT AT THE BARCLAYS GLOBAL HEALTHCARE CONFERENCE

On March 10, 2023 Bio-Techne Corporation (NASDAQ: TECH) reported that Jim Hippel, Executive Vice President and Chief Financial Officer, will present at the Barclays Global Healthcare Conference on Tuesday, March 14, 2023, at 2:35 p.m. EDT (Press release, Bio-Techne, MAR 10, 2023, View Source [SID1234628513]). A live webcast of the presentation can be accessed via the IR Calendar page of Bio-Techne’s Investor Relations website at View Source

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