On March 10, 2023 Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, reported that the company will host a conference call and live webcast on Thursday, March 23, 2023 at 4:30 p.m. ET to report fourth quarter and full year 2022 financial results and discuss recent business highlights (Press release, Heron Therapeutics, MAR 10, 2023, View Source [SID1234628520]).

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The conference call can be accessed by dialing (646) 307-1963 in the U.S. or (800) 715-9871 internationally. Please provide the operator with the passcode 7469717 to join the conference call. The conference call will also be available via webcast under the Investor Relations section of Heron’s website at www.herontx.com. An archive of the teleconference and webcast will also be made available on Heron’s website for 60 days following the call.

On March 10, 2023 Sumitovant Biopharma Ltd. ("Sumitovant") and Myovant Sciences Ltd. ("Myovant") reported that Sumitovant has successfully completed its acquisition of Myovant originally announced October 23, 2022 (Press release, Myovant Sciences, MAR 10, 2023, https://investors.myovant.com/news-releases/news-release-details/sumitovant-biopharma-completes-acquisition-myovant-sciences [SID1234628518]). Sumitovant has acquired all outstanding shares of Myovant not already owned by Sumitovant in an all-cash deal with a total transaction value of approximately $1.7 billion. With the completion of the acquisition, Myovant will be delisted from the New York Stock Exchange, and its shares will no longer be publicly traded.

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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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"We are excited to have officially completed our acquisition of Myovant and look forward to working together to address unmet needs in women’s health and prostate cancer," said Myrtle Potter, CEO of Sumitovant. "By combining our unique expertise, platforms and resources, we will be better positioned to drive the growth of Myovant’s products and accelerate the development of our robust combined pipeline."

"I am confident that bringing together the capabilities and strengths of Sumitovant and Myovant will best position us to continue delivering innovative therapies to patients sooner and accelerate the potential opportunities for ORGOVYX and MYFEMBREE," said Hiroshi Nomura, CEO of Sumitomo Pharma.

"I look forward to all we will be able to achieve with the support of Sumitovant and Sumitomo Pharma to expand the impact of our differentiated therapies and advance our clinical programs," said David Marek, CEO of Myovant. "We remain steadfast in our commitment to advance life-changing medicine and health equity for the patient communities we serve."

Advisors
J.P. Morgan Securities LLC served as financial advisor and Sullivan & Cromwell LLP served as legal counsel to Sumitovant and Sumitomo Pharma. Goldman Sachs & Co. LLC served as financial advisor to the Special Committee of the Board of Directors of Myovant and Skadden, Arps, Slate, Meagher & Flom LLP served as legal counsel to the Special Committee.

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.

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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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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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

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.